Insulet's power problems grow with FDA battery recall, Omnipod 5 charger notice

Just a few weeks after beginning a voluntary recall of the remote-control devices used with some of its insulin pumps—and warning that the safety action would take a multimillion-dollar hit to its bottom line—Insulet has received an FDA ruling on the matter.

The agency handed down a Class I rating to the recall, its most serious label, denoting a heightened risk of adverse injury or death linked to the affected product.

In this case, that product is the Personal Diabetes Manager, or PDM, a touchscreen device that connects wirelessly to an Omnipod Dash pump to control insulin dosing based on users’ mealtime calculations and glucose readings gathered by other devices. The PDM comes free with a user’s first shipment of Dash pods and stands in for the smartphones that can be used to control Insulet’s more advanced pumps.

Omnipod Dash

Last month, Insulet sent a letter to customers alerting them to a potential issue with the PDM devices’ batteries. According to the Oct. 17 missive, the company had received reports of the batteries swelling, leaking fluid or experiencing extreme overheating.

A subsequent investigation found that the controllers were especially at risk if they were charged to full capacity—including when left to charge overnight or for other extended periods of time—or if they had been used for longer than 18 months.

According to the FDA’s notice this week, the company has now tallied up 455 complaints linked to the battery issues, including three fires caused by extreme overheating, with no reports of injury or death.

The recall affects nearly 250,000 Omnipod Dash PDMs that were distributed in the U.S. between July 2018 and August of this year. Insulet pledged to replace all of the devices currently in use “in the coming months.” In a filing with the U.S. Securities and Exchange Commission, it warned that the move would cost between $35 million and $45 million, with the bulk of those charges showing up in the company’s third-quarter cost of revenue.

That prediction did come true: In its third-quarter earnings report earlier this month, Insulet noted a $36 million charge for the replacement devices.

But that wasn’t the only safety issue on Insulet’s docket. During an accompanying investor call, CEO Jim Hollingshead mentioned that the company was investigating “a couple of dozen complaints” about controllers used with its more advanced Omnipod 5 insulin pump.

“Our work is ongoing, and, if we ultimately decide to take a particular action, you can expect it to be swift and transparent,” he said at the time.

And indeed, barely two weeks later, that investigation has sparked an official medical device correction. In a Nov. 14 notice from the company, Insulet said it has received 24 reports of the Omnipod 5 controller’s charging port and charging cable “melting, deforming or discoloring due to heat generated by a poor connection between the cable and the port.”

Though that excess heat could cause “minor burns” or a fire, Insulet said it hasn’t received any reports of serious injuries linked to the charging issues. In the meantime, it has asked anyone using the controllers to keep an eye on their devices and charging equipment for signs of malfunction and to stop using them immediately if any are detected.

“We are working diligently to determine the cause and appropriate solution to correct this issue,” Michael Spears, Insulet’s senior vice president of regulatory affairs and compliance, wrote in the notice. “We will inform you via email and update our website when we have a solution.”