BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4232600 · Received September 11, 2014

    Report

    Report Number
    3004464228-2014-01342
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 13, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE TO FIRE AND PROPERLY INSERT THE CANNULA OR TO DETERMINE ITS ROOT CAUSE. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE REACHED 300 MG/DL SO SHE GAVE HERSELF A MANUAL SHOT OF 5 OR 6 UNITS (EXACT AMOUNT UNKNOWN). A SHORT TIME LATER SHE GAVE HERSELF ANOTHER SHOT OF THE SAME AMOUNT. WHEN SHE GOT HOME, SHE GAVE HERSELF YET ANOTHER SHOT. SHE CHECKED HER BLOOD GLUCOSE AND IT WAS AROUND 200 MG/DL. SHE ATE AND HER BLOOD GLUCOSE ROSE (READING NOT GIVEN). SHE REMOVED THE POD AND NOTICED THAT THE CANNULA NEVER INJECTED INTO HER SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563056 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40929

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR