BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 22004897 · Received May 12, 2025

    Report

    Report Number
    3004464228-2025-20621
    Event Type
    Injury
    Date Received
    May 12, 2025
    Date of Event
    April 18, 2025
    Report Date
    May 12, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000579
    PMA / PMN Number
    K231826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LOCKED DOWN SMARTPHONE: PHONE_CONTROL_ANDROID: OMNIPOD SOFTWARE APP VERSION: 3.1.1. SMARTPHONE OPERATING SYSTEM: UP1A.231005.007.S918USQS6CYB3. SMARTPHONE HARDWARE: SM-S918U. CGM SENSOR TYPE: G7. ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. PLEASE NOTE, THAT SECTION D IS CAPTURING THE DEVICE IDENTIFIERS AS REPORTED BY THE COMPLAINANT. THIS MAY NOT ALIGN TO THE DEVICE CONFIGURATION REPORTED IN H11, AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT.

    Description of Event or Problem · 0

    THE PATIENT REPORTED SHE WAS ADMITTED TO THE HOSPITAL WITH HYPOGLYCEMIA ON (B)(6) 2025. BLOOD GLUCOSE LEVELS HAD DECLINED TO 50 MG/DL WHILE WEARING THE POD. THE PATIENT REPORTED SHE USES U-200 INSULIN IN HER PUMP AND HAD BEEN INSTRUCTED BY HER HCP (HEALTH CARE PROVIDER) TO DELIVER A BOLUS THAT WOULD BE EQUIVALENT OF 30 UNITS OF U-100 (15 UNITS OF U-200), 30 MINUTES BEFORE MEALS. THE PATIENT REPORTED SHE DELIVERED A 15 UNITS BOLUS OF U-200 INSULIN IN ANTICIPATION OF AN UPCOMING MEAL. THE PATIENT REPORTED SHE FELL ASLEEP FOR 3 HOURS PRIOR TO EATING HER MEAL, WHICH RESULTED IN HER HYPOGLYCEMIC EVENT AND SUBSEQUENT MEDICAL ATTENTION. THE PATIENT DID NOT REPORT ANY SYMPTOMS ASSOCIATED WITH THEIR HYPOGLYCEMIA. THE PATIENT WAS TREATED WITH IV (INTRAVENOUS) FLUIDS AND DEXTROSE. THE PATIENT WAS DISCHARGED 3 DAYS LATER ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392830 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1K07282441 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Hospitalization