BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 14999849 · Received July 13, 2022

    Report

    Report Number
    3004464228-2022-11812
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Date of Event
    June 29, 2022
    Report Date
    June 29, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000114
    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

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED 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 CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.

    Additional Manufacturer Narrative · 0

    H6 DEVICE PROBLEM CODE ADDED: A150206.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED HIGH, OVER 500 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THEY BELIEVE THE CANNULA DID NOT INSERT. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652282 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 PP1K01182221 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female