BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 12174313 · Received July 15, 2021

    Report

    Report Number
    3004464228-2021-11785
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    May 22, 2021
    Report Date
    July 13, 2021
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120033
    PMA / PMN Number
    K192659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO BENDS OR KINKS WERE OBSERVED ON THE SOFT CANNULA. FLUID WAS SUCCESSFULLY ABLE TO PASS THROUGH THE ENTIRE FLUID PATH AND OUT THE DISTAL TIP OF THE SOFT CANNULA. A LEAK TEST WAS PERFORMED AND NO LEAKAGES WERE OBSERVED. THE DEVICE WAS RECEIVED WITH THE ADHESIVE PAD ATTACHED TO THE BOTTOM HOUSING. THE ADHESIVE PAD WELDS WERE OBSERVED TO BE INCORRECTLY INSTALLED. THIS DID NOT AFFECT INSULIN DELIVERY.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 400 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. "LIGHT" KETONES WERE ALSO PRESENT. AS TREATMENT, A MANUAL INJECTION OF INSULIN WAS DELIVERED AND A NEW POD WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069698 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L72232 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR