Insulin pumps tied to over 2,000 injuries recalled

pharmafile | February 14, 2020 | News story | Medical Communications Type 1 diabetes, diabetes, insulin, type 1, type 2, type 2 diabetes 

Over 300,000 insulin pumps have been recalled by Medtronic after injuries and one death were reported due to devices malfunctioning.

The company received 26,421 complaints regarding the malfunctions, which caused 2,175 injuries. The FDA said this is a Class I recall which is the most serious type of recall.

The recalled MiniMed 600 Series models either had a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pump’s reservoir compartment. If the cartridge is not locked into place an inaccurate amount of insulin may be delivered which can result in hypoglycemia. This can result in seizures and death.

Medtronic said in their latter to patients’ statement: “There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. The retainer ring can be broken, for example, as a result of dropping or bumping your pump on a hard surface. At Medtronic, patient safety is our top priority, and we are committed to delivering safe and effective therapies of the highest quality and reliability possible.”

The recalled products included a Model 630G, distributed between September 2016 and October 2019, and a Model 670G which was distributed between June 2017 to August 2019.

Conor Kavanagh

 

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