Medtronic’s Nov. 2019 recall of certain MiniMed 600 Series Insulin Pumps affects 322,005 units that were sold in the U.S. between 2016 and 2019. The device, used by patients with Type 1 diabetes, could be responsible for dangerous over- or under-deliveries of insulin. The recall has been rated “Class I” by the FDA—the most serious type of recall—due to the risks of injury attached to the defective devices.
Does the Medtronic Recall Affect Me?
The recall letter Medtronic sent specified two models of their MiniMed 600 Series Insulin Pump that may have a product defect:
- Model 630G (MMT-1715), sold between Sept. 2016 and Oct. 2019
- Model 670G (MMT-1780), sold between June 2017 and Aug. 2019
As of February 12, 2020, the company has received 26,421 complaints according to the FDA. Of those, at least 2,175 patients were harmed by the malfunction and 1 passed away.
What’s Wrong with the MiniMed Pumps?
These devices were recalled after patients complained about receiving the wrong insulin dosage. Medtronic investigated and found the “retainer ring” designed to hold the insulin reservoir in place could break or become disconnected from the device. Were the insulin reservoir to move, the pump can fail to deliver accurate amounts of insulin to the user.
Medtronic first recognized the issues with the retainer ring in Nov. 2019 and recommended users check their devices. The company advised patients to stop using a pump with retainer ring issues and offered to fix any pump where the part was loose, broken, or missing. However, the notice did not reference any complaints or injuries that had been reported at the time and advised users that, as long as the reservoir locked in place properly, they could keep using it.
According to complaints from users, patients have found the pump fragile, with the important retainer ring often damaged if the pump is dropped or even collides with another object. When this happens, the user—who generally is not aware of the defect or problem—can receive a dangerously inaccurate dose of insulin.
What Happened to Affected Patients?
No widespread data about the patient effects has come out but, as anyone familiar with diabetes knows, hypo- and hyperglycemia can cause many health problems, some of them serious. Medtronic has not indicated whether the pump is more likely to deliver too much or too little insulin. However, either could have serious consequences.
Hyperglycemia Caused by Insulin Underdose
Because the symptoms of hyperglycemia may have a slow onset and could be due to many causes, many diabetic individuals do not realize the reason for their illness at first. These symptoms include:
- Extreme thirst and frequent urination
- Loss of energy and/or drowsiness
- Trouble concentrating
- Unintentional weight loss
- Nausea and stomachache
If untreated, the condition can cause:
- Frequent infections
- Decreased immune capabilities
- Damage to blood vessels and nervous system
- Damage to organs including eyes, heart, and kidneys
- Ketoacidosis/diabetic coma
Hypoglycemia Caused by Insulin Overdose
If your insulin pump injects more that it is supposed to, your blood sugar can drop, often very quickly. Patients may experience:
- Headache and/or dizziness
- Irritability, anxiety, or nervousness
- Extreme sweating
- Nightmares (if asleep)
- Feelings of tiredness or confusion after waking up
The longer a hypoglycemic patient goes without proper treatment, the worse the symptoms will get. Severe signs of the condition include:
- Muscle weakness
- Difficulty speaking and/or seeing
Without an intervention to increase blood sugar, hypoglycemia can eventually cause seizures, loss of consciousness, cardiopulmonary failure, brain injury, and death.
What Should I Do?
If you use a MiniMed 600 Series Insulin Pump, we suggest you check the model number to see if it is included in the recall. Any patients who have been using faulty pumps should inspect the retainer ring (process illustrated in the recall letter, linked above) immediately and continue to use caution even if they do not see any defects. If you do note the problems Medtronic warned about, the company has released a support phone number for patients to call. It is also a good idea to discuss the potential issue with your doctor.
Any MiniMed users with the affected pump models who have been injured due to an insulin error since late 2016 may be entitled to compensation.
Our attorneys have been helping clients fight for and obtain justice after suffering injuries caused by defective Medtronic devices for years. Reach out today for your free and confidential consultation: you can call (800) 674-9725 or contact our team online.