Life-threatening MiniMed 600 Series Insulin Pump dosage issues lead to FDA warning letter over quality control
The FDA has sent an official warning letter to the huge medical device firm Medtronic plc. The recently received letter has castigated the company over “the inadequacy of specific medical device quality system requirements”. The FDA’s letter comes after a thorough inspection of Medtronic’s Northridge-based diabetes management, manufacturing, and sales division. One of the most perturbing issues stems from the company’s decision to recall MiniMed 600 Series insulin pumps, which was first initiated in November 2019, and which ultimately led to the FDA inspection.
At the end of 2019, both the MiniMed 630G and MiniMed 670G insulin pumps had to be recalled because of a problem with the clear retainer ring. Apparently, some of these vital devices had broken or missing rings, which could have led to users either receiving too much or too little insulin. With the potential for this issue to cause either hypoglycemia (low blood sugar level) or hyperglycemia (high blood sugar level), it’s clear to see why the FDA categorized it as a Class 1 recall: “Use of these devices may cause serious injuries or death.”
However, Medtronic recently broadened the scope of recall, as a safety measure, to include all MiniMed 600 Series insulin pumps that have a clear retainer ring (some units have an updated black retainer ring that functions properly). The company has provided users with an online serial number check form and is offering replacements for potentially faulty pumps. In response to the FDA warning letter, Medtronic has stated it “will apply resources from across the company and utilize external experts” to improve quality checks.
It has been reported that over 322,000 devices were affected by the recall and that at least one person had died in connection with the MiniMed 600 Series Insulin Pump broken or missing retainer ring issue. Those suffering from Type 1 diabetes and who rely on a Medtronic device for their insulin doses should make sure that it is not a model from the MiniMed 600 Series with a possibly faulty clear retainer ring. If it is, the advice given is to stop using the pump and contact Medtronic while resorting to manual insulin injections.