Insulet reports data breach affecting 29,000 insulin pump users

Mass-based medical device company Insulet has issued notice of a data breach that compromised the secure health information of 29,000 users of the recently recalled Omnipod DASH insulin management system.

In November, the FDA Posted a notice is about I remember the class. Personal Diabetes Manager for Insulet’s Omnipod DASH insulin management system, after complaints about the battery, including swelling, fluid leakage and overheating that could pose a fire hazard.

The company issued a voluntary device recall a month ago and notified consumers via an Urgent Medical Device Correction email.

In December, Insulet sent a follow-up letter asking customers to acknowledge that they had received a medical device correction letter with a link to a unique web page that inadvertently exposed IP addresses. What and whether customers used the DASH system and PDM for website performance and marketing partners.

According to one Copy In a letter Insulet sent to customers regarding the data breach, the company said “the configuration of web pages used to verify receipt exposed some limited personal information about customers”. Financial information, email addresses, passwords and social security numbers are not disclosed.

“We notified users that certain Protected Health Information (PHI), such as Omnipod DASH product usage and PDM usage, associated with an IP address, may be disclosed. An IP address is considered a personal identifier; However, they are associated with the. location or network through which a user connects to the Internet and are not necessarily unique to an individual,” an Insulet spokesperson said. Mobi Health News via email.

“lnsulet takes this incident very seriously. After discovering the privacy incident on December 6, 2022, we disabled all tracking codes on the related acknowledgment webpage on the same day to prevent further exposure of PHI. Where possible, we also request that our partners delete logs of IP addresses and unique URLs so that they cannot access this information.”

Insulet notified the US Department of Health and Human Services of the data breach on January 5. According to the database of the department.

A big trend

The company launched its Omnipod 5 automated insulin delivery system in the U.S. market in early August. FDA 510(k) clearance just over a year ago.

In November, Insulet released it 2022 Q3 earningsNoting that the company beat its revenue expectations with $326.1 million, a 23.7 percent increase in constant currency compared to $275.6 million last year.

Following DASH’s return, the company said it will ship an updated PDM to customers when it becomes available, which it says will cost an estimated $35 million to $45 million.

The FDA’s recall came a few days later The company issued a nationwide voluntary medical device “fix” for its Omnipod 5 controller Due to charging port and cable issues.

The publicly traded company has received 24 reports that heat generated by a poor connection between the cable and the port is causing the controller’s charging port or cable to melt or become discolored or damaged. Excessive heat may cause fire or minor burns if the user touches this part of the controller.

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