The U.S. Food and Drug Administration (FDA) has issued a warning letter to the medical device manufacturer Medtronic regarding their MiniMed 600 series insulin pump. The 600 series insulin pump is used to automatically disperse insulin at regular intervals.
In an inspection of Medtronic’s firm located in Northridge, California, the FDA found four major failures in the facility’s practices. According to the FDA, Medtronic’s “methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.”
In October 2021, the FDA reported that Medtronic recalled two other models of the MiniMed insulin pump. The MiniMed 630 and 670 pumps were recalled because the devices’ retainer rings could malfunction, leading to incorrect and life-threatening dosage errors. These recalls were also the basis of the FDA investigation.
According to the letter, Medtronic has known about these failures since 2016. The first major failure addressed by the FDA is Medronic’s lack of adequately established procedures for corrective and preventive action regarding the failure of these retainer rings.
Medtronic had conducted a classified investigation that determined the cause of the retainer ring failure and the consequences of that failure as early as June 2016. Re-designed pumps were not implemented until 2019.
Despite these efforts by Medtronic, the FDA determined that there was a reasonable probability that the use of, or exposure to, the pumps manufactured with the clear retainer ring would cause serious adverse health consequences, including severe hypoglycemia, severe hyperglycemia, diabetic ketoacidosis, or death and subsequently issued the October recall.
The FDA also determined that Medtronic:
- Failed to adequately implement procedures for corrective and preventive action
- Failed to adequately analyze all sources of quality data
- Failed to identify actions needed to correct nonconforming product
- Did not appropriately verify or validate the change to their device to ensure corrective and preventive actions taken were effective and did not adversely affect the finished device
- Did not submit an accurate risk calculation to the FDA
- Did not identify the actions needed to control devices already in distribution
In addition to the physical deformity in some MiniMed 600 pumps, the FDA also noted that the Medtronic MiniMed 508 Insulin Infusion Pump and the MiniMed Paradigm Insulin Infusion Pumps had cybersecurity weaknesses that allowed unauthorized access from potential bad actors.
The FDA has evaluated Medtronic’s response and determined that it is inadequate due to the fact that Medtronic has “not yet provided evidence of implementation for all corrections and corrective actions.” If Medtronic fails to comply “promptly” and correct the noted deficiencies, the FDA may take regulatory action without further notice, including the use of seizure, injunction, and civil money penalties.