In February the U.S. Food and Drug Administration (FDA) announced that Medtronic had recalled about 322,000 defective insulin pumps used by type 1 diabetics. The recall was issued in November.
Insulin pumps are small computerized devices designed to deliver precise doses of insulin based on a patient’s blood sugar levels. The pumps from Medtronic’s MiniMed 600 series can deliver too much or too little insulin due to missing or broken retainer rings which are needed to hold the insulin cartridge in place.
The consequences of incorrect insulin dosing can be severe. Too much or too little insulin, a blood sugar regulating hormone normally produced by the pancreas but which is lacking in individuals with type 1 diabetes, can cause hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar). Hypoglycemia can cause visual disturbances and confusion as well as more serious consequences such as loss of consciousness, seizure and death. Persistent hyperglycemia can cause complications involving the eyes, heart, nerves and kidneys, while severe hyperglycemic episodes can cause diabetic coma.
The FDA’s Feb. 12 statement reported that Medtronic had received 26,421 complaints of malfunctioning pumps from its MiniMed 600 series and was aware of 12,175 injuries and one death.
Insulin Pump Recall Details
When a product is recalled, it means that it violates FDA law and the manufacturer must inspect, repair, modify, adjust and/or destroy the product.
The FDA identifies this recall as a Class I recall, the most serious type. Class I recalls carry “reasonable probability” that the product will cause serious adverse health consequences or death. A Class II recalled product is one that may cause temporary or medically reversible adverse health consequences, or have a “remote” probability of serious adverse health consequences. The least serious recall, Class III, refers to a recalled product that is not likely to cause adverse health consequences.
Recalled insulin pumps include all lots of Model 630G with SmartGuard (MMT-1715) manufactured before October 2019 and distributed between September 2016 and October 2019 and Model 670G (MMT-1780) lots manufactured before August 2019 and distributed from June 2017 to August 2019. Model numbers of pumps are printed on the bottom or back of the devices.
In Brief: What Patients Should Do
Medtronic has advised patients to examine the retainer ring of their pump. The company posted an information sheet with detailed instructions, photos and an FAQ list showing how to do this. Medtronic will only replace pumps if the retainer rings are defective. Customers or health care providers with questions or who need additional support regarding the current recall can contact Medtronic’s 24-hour technical support at 877-585-0166.
If the reservoir doesn’t lock into the pump or if the retainer ring is loose, damaged or missing, stop using the pump and contact Medtronic’s support line at 877-585-0166 for a replacement. If the product is defective, Medtronic advises patients to follow their doctor’s directions for manual insulin injections instead.
If Working Properly:
If the pump retainer ring is working, patients can continue to use the pump. However, patients are advised to examine the locking ability of the reservoir and retainer ring during each reservoir and infusion set change to ensure the reservoir continues locking correctly. If the pump is accidentally dropped, patients should check it as well as the retainer ring for damage. Patients should also take care not to insert the reservoir back into the pump while connected, as that could result in mistakenly administering a large amount of insulin.
Prior Medtronic Recalls
This current recall follows a November 2019 recall of MiniMed Models 500 and 503 Remote Controllers and a June 2019 recall of the MiniMed 508 and certain MiniMed Paradigm models. Both recalls came after the FDA warned that it was possible for a nearby individual to wirelessly hack into the computerized insulin pumps and change pump settings to over-deliver insulin or stop the pump altogether.