Description of Event or Problem · 0
SUBJECT: OMNIPOD 5 APP -- LACK OF COMPATIBILITY WITH IPHONE 17 CREATING MEDICAL RISK I AM SUBMITTING THIS COMPLAINT REGARDING INSULET CORPORATION'S OMNIPOD 5 INSULIN DELIVERY SYSTEM AND ITS ASSOCIATED IPHONE APP. AS OF OCTOBER 2025, INSULET HAS NOT PROVIDED COMPATIBILITY FOR IPHONE 17 MODELS, LEAVING USERS UNABLE TO OPERATE OR MONITOR THEIR OMNIPOD 5 SYSTEMS THROUGH THE APP. THIS SITUATION POSES A POTENTIAL SAFETY RISK FOR INSULIN-DEPENDENT INDIVIDUALS WHO UPGRADED DEVICES WITHOUT PRIOR WARNING THAT THE APP WOULD BECOME NONFUNCTIONAL. INSULET DID NOT ISSUE PROACTIVE COMMUNICATION TO ITS USER BASE ABOUT THIS LIMITATION, DESPITE IPHONE 17 MODELS BEING RELEASED PUBLICLY AND THE APP BEING CENTRAL TO DAILY DIABETES MANAGEMENT. SPECIFIC CONCERNS: ¿ NO ADVANCE NOTIFICATION THAT UPGRADING TO AN IPHONE 17 WOULD RENDER THE OMNIPOD 5 APP INOPERABLE. ¿ THE SYSTEM DEPENDS ON THE APP FOR VISIBILITY AND CONTROL OF INSULIN DELIVERY, CREATING THERAPY INTERRUPTIONS AND SAFETY GAPS. ¿ THE DEVICE COMPATIBILITY PAGE REFLECTED THE LIMITATION ONLY AFTER CUSTOMERS EXPERIENCED FAILURES. ¿ NO CLEAR TIMELINE FOR RESTORING COMPATIBILITY. OUTCOME REQUESTED: INVESTIGATE WHETHER INSULET MET POST-MARKET SAFETY AND COMMUNICATION OBLIGATIONS UNDER 21 CFR PART 803 AND RELATED REGULATIONS, SPECIFICALLY REGARDING TIMELY CONSUMER NOTIFICATION AND RISK MITIGATION. PRODUCT INFORMATION: ¿ PRODUCT: OMNIPOD 5 INSULIN DELIVERY SYSTEM ¿ MANUFACTURER: INSULET CORPORATION ¿ MODEL: OMNIPOD 5 APP FOR IPHONE (LATEST RELEASE AS OF OCTOBER 2025).