BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 15068264 · Received July 20, 2022

    Report

    Report Number
    3004464228-2022-12486
    Event Type
    Malfunction
    Date Received
    July 20, 2022
    Date of Event
    June 29, 2022
    Report Date
    July 14, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    PMA / PMN Number
    K203768
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO 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.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D1 - BRAND NAME CHANGED FROM UNAVAILABLE TO OMNIPOD 5 POD. D2A - COMMON DEVICE NAME CHANGED FROM UNAVAILABLE TO ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP. D2B - PROCODE CHANGED FROM UNAVAILABLE TO QFG. CORRECTION TO D(4): MODEL NO CHANGED FROM PT-000536 TO PT-000435. CATALOG NO CHANGED FROM UNAVAILABLE TO POD-BLE-H1-520. UNIQUE IDENTIFIER (UDI) # CHANGED TO (B)(4). CORRECTION TO G(5): PMA/510(K) # CHANGED FROM UNAVAILABLE TO K203768.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL REACHED 266 MG/DL. THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE ABDOMEN. IT WAS NOTED THAT THE ADHESIVE WAS NOT SECURE AND THE CANNULA DISLODGED FROM THE SITE. HYPERGLYCEMIA TREATED WITH A NEW POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241290 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 PP1K02072211
    991175 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 PP1K02072211

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female