- Insulet issued what it called an "urgent" medical device correction Thursday regarding a glitch in the software portion of all Omnipod Dash insulin delivery systems.
- The so-called personal diabetes manager, or PDM, component of the system may "on rare occasions" advise an inaccurate bolus insulin amount based on a blood glucose reading that is more than 10 minutes old, which could lead to incorrect dosing, Insulet described.
- As of Thursday, there had been 11 complaints and no injuries related to the issue. The company said it's notifying affected customers and plans to make replacement devices available beginning in March to all Omnipod Dash users once a software fix is tested and finalized. At this time, the company cannot perform remote software updates.
Insulet received 510(k) clearance for Omnipod Dash in June 2018. This past September, FDA authorized the technology as an alternate controller enabled, or ACE, pump, setting it up for use in Insulet's forthcoming Horizon automated insulin delivery system. That system will be compatible with Dexcom continuous glucose monitors. Insulet has said it hopes to launch Horizon in the second half of 2020. It may offer status updates on its earnings call scheduled for Feb. 25.
Insulet said the issue with Dash can occur in cases when the user does not exit the handheld PDM's bolus calculator as designed or in the event a system alarm interrupts a bolus calculation. If a user were to follow through with the potentially unsuitable bolus, that under or over delivery of insulin could result in hypoglycemia or hyperglycemia. The on-body, hardware portion of the system, known as the pod, is not affected.
The company said Thursday the system is "safe for continued use and distribution." Insulet does not disclose how many people are using Dash worldwide. It expects an immaterial fourth quarter charge related to the correction.
Insulet said it's taking the action "voluntarily with the knowledge of the FDA."
The notice comes a day after the agency flagged a potential safety issue with certain Medtronic insulin pumps. Although the source of risk was different (certain Medtronic pumps had a hardware flaw) the possible outcome was the same: under or over delivery of insulin. At the time of FDA's notice, there had been more than 26,000 complaints, 2,175 injuries and one death related to the issue.
Analysts at Stifel noted that while Wednesday's FDA notice on Medtronic did not reflect "new news," it "could have incremental 'negative reputation' implications and could also give current [Medtronic] users yet another reason to consider converting to a competitor device."
And 2020 could be a particularly vulnerable year for Medtronic's diabetes business due to more than 100,000 expiring warranty units — although relatively few of those likely fall under the recalled models, the analysts said.
With the Insulet and Medtronic defects top of mind, "Issues like these are likely to continue for all current and future insulin pump manufacturers and underscores, again, that more work needs to be done to make pumps attractive and reliable," the Stifel analysts said.