BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH, PODS 10-PACK

    MDR report key: 16895545 · Received May 9, 2023

    Report

    Report Number
    3004464228-2023-11835
    Event Type
    Malfunction
    Date Received
    May 9, 2023
    Date of Event
    May 7, 2023
    Report Date
    May 8, 2023
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000112
    PMA / PMN Number
    K211575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A DIFFERENT LOT NUMBER WAS PROVIDED FROM THE LOT REPORTED AND NOTED ON THE INITIAL MDR. CORRECTION TO D1- BRAND NAME FROM OMNIPOD 5 POD TO OMNIPOD DASH, PODS 10-PACK CORRECTION TO D2A- COMMON DEVICE NAME FROM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP TO PUMP, INFUSION, INSULIN CORRECTION TO D2B- PROCODE CHANGED FROM QFG TO LZG CORRECTION TO D(4): MODEL NO CHANGED FROM PT-000536 TO PT-000029 CORRECTION TO D(4): MODEL NO CHANGED FROM PT-000536 TO PT-000029 CORRECTION TO D(4): CATALOG NO CHANGED FROM POD-BLE-H1-525 TO POD-BLE-C1-529 CORRECTION TO D(4): LOT NUMBER FROM PH1K11032241 TO PD1K09252231 CORRECTION TO D(4): EXPIRATION DATE FROM 5/3/2024 TO 3/25/2024 CORRECTION TO D(4): UNIQUE IDENTIFIER (UDI) # CHANGED FROM (B)(4)CORRECTION TO G(4): PMA/510(K)# FROM K203768 TO K211575 CORRECTION TO H(4): DEVICE MFG DATE CHANGED FROM (B)(6)2022.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 30 MMOL/L (540 MG/DL). THE POD WAS LEAKING WHILE WORN FOR BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2025881 OMNIPOD DASH, PODS 10-PACK PUMP, INFUSION, INSULIN LZG INSULET CORPORATION PT-000029 PD1K09252231 20385082000112
    726638 OMNIPOD DASH, PODS 10-PACK PUMP, INFUSION, INSULIN LZG INSULET CORPORATION PT-000029 PD1K09252231 20385082000112

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male