| Developers: | Medtronic |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
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2024: Serious marriage found in insulin pumps: they suddenly turn off
In early October 2024, it became known that Medtronic was recalling a number of MiniMed automated insulin supply systems due to battery problems. Insulin pumps began to suddenly turn off, threatening the condition and life of patients.
In late July 2024, Medtronic warned customers to monitor built-in alerts about the state of the insulin pump battery and contact the company in case of a sudden change in battery life. They began investigating the issue after receiving a number of reports that battery life had been reduced, Medtronic said. Comprehensive analysis showed that this phenomenon is characteristic of insulin pumps that fell or hit other objects at least once. The company attributed this problem to damage to internal electrical components.
In addition, it turned out that due to this defect, notifications about the state of the battery come later than indicated in the user manual. This can cause the battery to run out and the pump to stop supplying insulin significantly earlier than expected. In turn, stopping insulin supply may be accompanied by health risks such as the development of hyperglycemia or diabetic ketoacidosis (DKA), life-threatening and requiring medical intervention.
Medtronic received 170 reports of hyperglycemia cases and 11 reports of diabetic ketoacidosis cases from January 2023 to September 2024 in the U.S., all of which were potentially linked to the problem.
According to Medtronic, the problem persists even after the battery is replaced. The company asked that users always carry an additional set of new or fully charged batteries in case of an emergency warning about pump discharge.[1]
2023
Suspected of draining data from Google diabetics and other companies for advertising purposes
In early September 2023, it became known that a lawsuit was filed against Medtronic by users of its products. One of the largest manufacturers of medical devices is accused of illegally transferring patients' personal data to third parties, including Google and other organizations.
The case involves the MiniMed division as part of Medtronic. The problem is related to the InPen smart insulin pen mobile app with syringe functions. The program allows you to track drug doses, receive reminders and transmit information to the attending physician. The use of personal data is governed by Medtronic's confidentiality policy agreement. However, the company used patients' personal information for purposes outside of the agreement, the lawsuit alleges. This is, in particular, the personalization of advertising messages.
 | Despite its commitment to protect the privacy and security of patients' personal information, MiniMed has made a conscious decision to use tracking tools on its digital platforms to obtain personal health data of its customers. That information was provided to third parties, including Google, for marketing and analytics purposes and ultimately to boost revenue and profits, the lawsuit said. |  |
The initiator of the proceedings claims to use the postal service, and Gmail therefore the transfer of his medical data to Google allows him to reveal his real identity. It is assumed that other patients will join the process, which will give the lawsuit the status of a collective. Medtronic said it had not received court documents as of early September 2023 but was ready to consider the complaint.[2]
Faulty Medtronic insulin pump leads to death of man
On August 8, 2023, it became known that a lawsuit was filed against Medtronic, one of the largest manufacturers of medical devices, in connection with the death of a person. The failure of the automated insulin pump Medtronic MiniMed caused the death of Missouri resident Michael Domanowski.
MiniMed devices are small computerized devices that deliver insulin to patients with during the day diabetes mellitus through a catheter. The pumps connect wirelessly to both the glucose monitoring system and the remote controller. Due to serious design flaws, the MiniMed 600 series and MiniMed 780G models were recalled in 2009, 2013, 2014, 2017 and 2020. The problem is related to defects in the locking ring, which does not fix the insulin cartridge in place. Due to this, insufficient or excessive dosage of the drug may be observed. The defect caused 2,175 cases of harm to the health of patients and one death.
The lawsuit against Medtronic was filed by John Frank, the property manager of the deceased Domanowski. The case file says the man filled the pump with insulin before going to bed. However, the device delivered a weekly supply of the drug to the patient's body in a short period of time. As a result, Domanowski died of severe hypoglycemia: an autopsy showed extremely low blood sugar.
The MiniMed pump used by Domanowski was later recalled due to the risk of malfunction and overdose, the lawsuit notes. Medtronic staff contacted the family within days of the man's death to warn of the recall. However, the case says it was an attempt to "cover up your own misconduct." The plaintiffs, among other things, are seeking damages and a fine on Medtronic.[3]
2021
User deaths and device recalls
On October 5, 2021, Medtronic notified customers by email and phone that the recall had been extended to replace all MiniMed 600 series insulin pumps that contain a transparent container ring.
Serious injuries and deaths have been reported with the MiniMed 600 series insulin pumps, but these events may not have been directly related to the damaged clear fixing rings that are the basis for this recall, the FDA said. Medtronic is recalling the affected pumps for free replacement of any pump with a transparent locking ring to a pump with an updated black locking ring, even if the transparent locking ring is not damaged and regardless of the warranty status. The MiniMed locking ring helps fix the insulin cartridge in the pump reservoir compartment. If the cartridge is not fixed, insufficient or excessive insulin supply can occur, which can cause low blood sugar or high blood sugar levels, which can be life-threatening.
Initially, the review affected 322 thousand MiniMed 630G and MiniMed 670G pumps in the United States. The Food and Drug Administration (FDA) confirmed that the recall applies to the MiniMed pumps of the 630G model, distributed from September 2016 to February 2020, as well as the MiniMed pumps of the 670G model, distributed from May 2015 to December 2020. In total, 463 thousand devices were recalled in the United States.
| | As with any therapy, there are risks to consider when a patient and their healthcare provider decide to use a pump to administer insulin instead of several daily injections. The body of evidence from controlled large-scale clinical trials and real-world studies strongly supports the safety and benefits of insulin pump therapy, "said Medtronic Managing Director Robert Vigersky. | |
Medtronic released a statement saying that the analysis of safety data for the MiniMed 600 series of insulin pumps with transparent fixing rings did not confirm that adverse events were directly related to damaged transparent fixing rings, but the company is actively accelerating the replacement plan so that customers can strive for the highest possible reliability and quality of insulin pumps from Medtronic.[4]
Announcement of Medtronic Extended infusion kit for diabetics that can be worn for 7 days
In mid-April 2021, Medtronic released the world's first Medtronic Extended infusion kit for diabetics, which can be worn for up to 7 days. Thanks to this, patients will be able to safely use the insulin pump twice as long as usual. Read more here.
2020: Recall of defective insulin pumps due to 'serious' problem
In mid-February 2020, Medtronic recalls hundreds of thousands of Minimed insulin pumps due to the threat to patients' lives. In the US market alone, 322,005 MiniMed 630G and 670G pumps are being recalled, which the FDA regulator said have a "serious" problem.
Due to a production defect, the system is devoid of a locking ring designed to lock the insulin cartridge in the pump reservoir compartment. If the cartridge is not fixed in place, the pump can inject too little or too much insulin, potentially threatening the lives of patients. Medtronic received 26,421 malfunction complaints as well as 2,175 reports of injuries related to the issue.
Medtronic concluded that the locking ring was not strong enough to properly withstand accidental impacts. A Medtronic spokeswoman said lock ring suppliers provided parts that met Medtronic's specifications. Therefore, after analyzing the damage, Medtronic improved the design of the pump so that the devices better resist accidental fall or impact on a hard surface. In particular, engineers have improved the design of the locking ring. In October 2019, Medtronic began the transition to production of new models.
The devices affected include MiniMed 630G (MMT-1715 model) pumps manufactured before October 2019 and distributed on the market from September 2016 to October 2019, as well as MiniMed 670G (MMT-1780 model) pumps manufactured before August 2019 and distributed on the market from June 2017 to August 2019.
Medtronic notified customers of the problem and offered to check the lock ring. The manufacturer strongly recommends stopping using the pump if the insulin cartridge is not fixed or if the retaining ring is loose, damaged or missing.[5]
2019
Medtronic insulin pumps do not function in airplanes
In mid-July 2019, Medtronic warned patients that MiniMed 600 series insulin pumps could stop acting on the plane or in other situations with a rapid change in air pressure. The problem identified concerns more than 189,000 MiniMed insulin pumps worldwide.
The Food and Drug Administration (FDA) has classified this feature of the device as a Class 2 problem, that is, a moderate defect that causes temporary problems with a low probability of serious adverse effects. The defect refers to MiniMed 670G, 640G, 630G and 620G models that have a non-electronic keypad.
It is she who ceases to act with a rapid change in atmospheric pressure, usually during takeoff and landing of the aircraft. In most cases, the patient may not even notice this problem - it resolves on its own when atmospheric pressure normalizes. Another solution to the problem is indicated in the operating manual, which prompts the user to remove and put on the battery cover again.
The problem has long been known to manufacturers, and the first warnings were sent to buyers back in 2017. Regulators do not require the company to withdraw these insulin pumps from the market. Their task is to warn patients. The Medtronic letter to customers says that if the pump user notices the buttons on the keyboard sticking when atmospheric pressure changes, there is no need to worry - in fact, the device continues the basic administration of insulin. At this time, the patient will not be able to program bolus administration of the drug or suspend delivery, since the buttons will temporarily stop functioning, but this problem will be resolved by itself within 30 minutes.[6]
Recall of thousands of insulin pumps that can be remotely turned off
At the end of June 2019, Medtronic recalled thousands of MiniMed insulin pumps due to the potential risk of hacking. The Food and Drug Administration (FDA) found out that due to a software vulnerability, these devices can be turned off remotely and sent a warning to the company.
The MiniTed 508 and MiniMed Paradigm series insulin pumps have been withdrawn from the market. Patients using these pumps are advised to change them to models that are better equipped to protect against hackers. Although there have been no reports of patients who may have suffered from this defect so far, the risk of harm remains too high.
Identified cybersecurity vulnerabilities suggest that hackers can connect to the MiniMed insulin pump and change its settings using a wireless network. This poses a threat of overdose or cessation of insulin administration, which can lead to hypo- or hyperglycemia and diabetic ketoacidosis.
The manufacturer explained that it could not fix the bug in the MiniMed 508 and Paradigm insulin pump software using a regular update or patch to fix vulnerabilities. The company has already contacted 4,000 customers and is working with distributors to identify the rest of the patients who could purchase these devices. Medtronic offers patients free of charge to replace defective insulin pumps with alternatives with more robust cybersecurity settings. All doctors and patients who may be associated with this problem have been sent a written warning.
Regulators urge medical equipment manufacturers around the world to remain vigilant about their products - monitor and assess the risk of cybersecurity violations, and take the initiative to identify and correct new defects.[7]
2018: Medtronic insulin pumps could have caused more than 2.6 thousand deaths and 150 thousand health injuries
In late November 2018, the International Consortium of Investigative Journalists (ICIJ) released the results of an investigation called Implant Files into implant problems. It follows from the report that Medtronic may be involved in 9.3 thousand deaths and 292 thousand injuries sustained by patients in the United States alone.
One in five Medtronic implants is problematic, according to the ICIJ, which is twice as good as other manufacturers. Reporters investigated 36 countries and noted that authorities in Japan, Norway and Australia pointed to Medtronic products as the source of the highest number of complaints in the previous five years.
As a result of the investigation, one of the following conclusions was made: since 2008, insulin pumps or their components produced by Medtronic for diabetes patients could cause more than 2.6 thousand deaths and 150 thousand health injuries in the United States.
In Finland, Germany, Canada, India and the United States, interviewed patients or family members of the victims said that Medtronic is in no hurry to respond to problems with insulin pumps and does not always inform people about the risks associated with them.
The Food and Drug Administration (FDA), the ICIJ said, sees little surprise in the large number of complaints about Medtronic, as the regulator said the company makes most of the medical devices.
2017: Recall of infusion systems used in insulin pumps
In September 2017, Medtronic announced a global recall of infusion systems used in all insulin pumps from the American manufacturer. A malfunction can lead to a dangerous decrease in glucose levels.
Infusion is used to deliver insulin from the pump to the body of someone with diabetes. The system consists of a disposable tube, a tube connector and a catheter that implants under the skin in the abdomen.
The ventilation membrane, which can be blocked by fluid during insulin delivery, turned out to be problematic in this component. The result may be an overabundance of insulin and, as a result, hypoglycemia.
Medtronic recommended that customers apply only those infusion systems that use new or updated membranes (released since April 2017). Defective products are being recalled. How much we are talking about is not specified, but it is known that about 5 thousand products are being recalled in India. They are subject to replacement with serviceable products.
| | Our Medtronic Diabetes team will work as quickly as possible to complete the exchange of devices for new or improved ones, as well as provide full support to our customers as part of this process, said Francine Kaufman, head of medical affairs at Medtronic's diabetes division. | |
Users of insulin pumps can independently check whether their devices fall under the recall program on the manufacturer's website. Medtronic noted that the online check was implemented due to the fact that revocable infusion systems are used in all the company's pumps.
Medtronic warned of a recall of all regulators in the world, including the Food and Drug Administration (FDA).[8]
2016: Medtronic and Samsung create first Android program to monitor blood glucose
On October 24, 2016, the company Medtronic announced the release of MiniMed Connect for. operating system Android The application was developed in conjunction with a South Korean manufacturer. smartphones Samsung Electronics More. here
Notes
- ↑ https://www.drugdeliverybusiness.com/medtronic-recalls-minimed-pumps-battery-issues/
- ↑ Medtronic sued for allegedly sharing ‘treasure trove’ of diabetes patient data with Google
- ↑ Medtronic MiniMed Lawsuit Filed Over Wrongful Death from Insulin Pump Overdose
- ↑ BREAKING: Medtronic expands Class I recall of MiniMed 600 series insulin pumps
- ↑ FDA says Medtronic MiniMed insulin pump recall is serious
- ↑ FDA recalls Medtronic 600-series MiniMed insulin pumps
- ↑ FDA Recalls Some Medtronic Insulin Pumps Because of Cybersecurity Concerns
- ↑ Medtronic Issues Wide-Ranging Infusion Set Recall
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