Dive Brief:
- In January, Medtronic initiated a recall affecting over 175,000 MiniMed automated insulin pumps due to programming complications that could result in the under-delivery of insulin, potentially causing patient harm.
- The recall, which will not require the retrieval of devices, is due to new or replacement insulin pumps being used as if previous basal rates or other settings were pre-programmed, but the devices do not come with pre-programmed settings. The confusion can cause devices to not deliver insulin to patients, which can lead to serious injuries. Medtronic is contacting customers to make sure that settings are programmed in devices before use and the settings are saved correctly. A company spokesperson told MedTech Dive that injuries have been reported due to the issue, but they did not give a specific number of reports.
- The Food and Drug Administration labeled the recall a Class II event, saying that product labeling does not appropriately notify users of the potential programming complications. While the recall will not require device retrieval, it is another product safety instance for Medtronic's diabetes group, which has dealt with multiple recalls over the last several years and received an FDA warning letter for safety problems.
Dive Insight:
Medtronic first identified that devices were being used without being programmed or programmed settings not being saved correctly in April 2021, according to the company. After looking into the problem, Medtronic initiated a recall.
The recall began in January, according to the FDA, and Medtronic sent out notifications in February.
The problems were happening with new and replacement devices, so the company initially determined that the recall would impact devices sent out between September 2021 and February, ultimately affecting 175,801 units across multiple MiniMed types.
The company has now sent notifications out to customers who received new or replacement devices since February, according to an emailed statement.
A Medtronic spokesperson said that the company did not go further back than September because any issues with new or replacement pumps would likely have been reported and addressed before that point.
Medtronic said in a February recall notification, "Serious injuries have been reported with the use of the MiniMed 600 series and MiniMed 700 series insulin pumps which may be directly attributed to not setting basal rates." One death has also been reported, although the company said that "a review by independent clinical experts did not directly attribute this to not setting basal rates."
Medtronic said in an emailed statement that as of April 8, there have been no additional reports of patient deaths.
In an entry in its recall database, the FDA said that product labeling does not notify customers that devices will operate on default settings and is lacking other information to avoid the complications.
"Current device labeling does not clearly identify that these insulin pumps are capable of functioning with the default basal setting of 0.0 units/hr for all 24 hours and that no error message will appear if the default basal setting remains active," the FDA stated. "Furthermore, the labeling for the affected devices does not highlight that saving the basal settings requires multiple steps and failure to complete all steps will not save the new basal settings, nor that the steps required to set and save a basal profile and other parameters which are used as part of the bolus calculator function are different."
A Medtronic spokesperson said that the company is currently reviewing materials that come with devices and is in the process of making changes. The company is notifying customers, distributors and healthcare providers of the recall.
Class II recalls are considered to be "a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote," according to the FDA. The agency labeled the recall March 31.
The recall is not a result of the FDA's inspection of Medtronic's diabetes headquarters last year, and it is not tied to problems the agency outlined in its warning letter. Although, the warning letter did highlight safety problems with MiniMed pumps, and Medtronic has issued two recent recalls for the pumps, one affecting about 463,000 devices in the U.S. after it was expanded following the agency's inspection.
The latest recall affects new and replacement devices sent to first-time customers, customers that were scheduled to receive new devices and also customers who may have received a replacement device due to a past recall, according to the Medtronic spokesperson.
This article was updated to include a statement from Medtronic regarding the current number of reports of patient deaths.
