Description of Event or Problem · 0
(B)(6) IS A 41-YEAR-OLD MOTHER OF FOUR WHO ALSO HAPPENS TO BE A TYPE 1 DIABETIC, ALONG WITH HER 11-YEAR-OLD DAUGHTER. BOTH OF THEM ARE ON THE OMNIPOD 5 ALONG WITH THE DEXCOM G6, CONTINUOUS GLUCOSE MONITORING SYSTEM. ON FRIDAY, (B)(6) 2024, (B)(6) PUMP CONTROL DEVICE (PDM) FAILED FOR THE FIFTH TIME IN AS MANY YEARS. IT WAS LESS THAN ONE YEAR OLD AT THE TIME OF FAILURE. SHE IMMEDIATELY CALLED THE INSULET CORPORATION TO HAVE THEM SEND AN EMERGENCY PDM REPLACEMENT. BECAUSE IT WAS LATE ON A FRIDAY NIGHT SHE WAS TOLD THAT IT WOULD NOT BE SHIPPED OUT OVER THE WEEKEND. AS RESULT, SHE WAS UP FOR MUCH OF THE NIGHT FIGHTING HIGH BLOOD SUGARS WITH EMERGENCY BACKUP INSULIN INJECTIONS THAT SHE THANKFULLY HAPPENED TO HAVE WITH HER. UNFORTUNATELY, OMNIPOD PDM FAILURES ARE NOT A RARITY. FOR INDIVIDUALS LIKE (B)(6) WHO ARE INSULIN DEPENDENT, THIS CAN PRESENT A GRAVE RISK TO MORBIDITY AND/OR MORTALITY. I AM REQUESTING THE FDA INVESTIGATE THE QUALITY CONTROL OF THESE DEVICES. IF THE INSULET CORPORATION CANNOT PRODUCE HIGHLY RELIABLE PDM'S, THEY MUST BE REQUIRED TO PROVIDE A BACK-UP PDM TO EVERY PATIENT ON THE DEVICE. ADDITIONALLY, THE INSULET CORPORATION SHOULD BE MANDATED TO PROVIDE EMERGENCY OVERNIGHT SHIPPING FOR ANY CONFIRMED DEVICE FAILURE. IN CONTRAST, MEDTRONIC, ANOTHER TUBED INSULIN PUMP COMPANY, SHIPS OVERNIGHT TO INDIVIDUALS WITH A PUMP FAILURE.