Mass-based medical device company Insulate issued notice of a data breach that may have compromised the protected health information of 29,000 users of its recently recalled OmniPod DASH insulin management system.
In November, the F.D.A. Posted a notice regarding complaints about the battery, including swelling, fluid leakage and overheating that could pose a fire hazard, in Insulate’s Omnipod Dash Insulin Management System Personal Diabetes Manager’s Class I remember.
The company issued a voluntary device recall a month ago and immediately notified users via email of a medical device correction.
In December, Insulet sent a follow-up letter requesting users that they had received a medical device correction letter with a link to a unique webpage that inadvertently exposed IP addresses and whether the customer used the DASH system and PDM. Use for website performance and marketing partners.
according to a In a copy of Insulate’s letter sent to customers regarding the data breach, the company said that “the configuration of web pages used for receipt verification exposed some limited personal information about customers”. Financial information, email addresses, passwords and social security numbers were not disclosed.
“We informed customers that certain protected health information (PHI), such as Omnipod DASH product use and PDM use associated with an IP address, may be exposed. IP addresses are considered personal identifiers; however, they are associated with are the location or network through which a user connects to the Internet and are not necessarily unique to an individual,” a spokesperson for Insulate explained. MobiHealthNews Via email.
“lnsulet takes this incident very seriously. After we became aware of the privacy incident on December 6, 2022, we disabled all tracking code on the relevant acknowledgment web page the same day so that there is no further exposure of PHI. Where possible However, we are also requesting that our partners remove logs of IP addresses and unique URLs so that they cannot continue to access that information.”
Insulate notified the US Department of Health and Human Services about the data breach on January 5th. According to the database of the department
The company launched its OmniPod 5 Automated Insulin Delivery System in the full US market in early August after receiving FDA 510(k) clearance just a year ago.
In November, Insulate released this Earnings for the third quarter of 2022, noting that the company beat its revenue expectations with $326.1 million, an increase of 23.7% in constant currency compared to $275.6 million over the previous year.
Following the DASH recall, the company said it would ship an updated PDM upon availability to users, which it said would cost an estimated $35 million to $45 million.
FDA’s recall classification comes days later The company issued a nationwide voluntary medical device “correction” for its Omnipod 5 controller due to charging port and cable issues.
The publicly traded company received 24 reports that heat generated due to a poor connection between the cable and port is causing the controller’s charging port or cable to melt or discolor or deform. The excessive heat could result in a fire or minor burn if a user touches that area of the controller.