BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4201407 · Received September 17, 2014

    Report

    Report Number
    3004464228-2014-01381
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 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 PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED FAILURE OF THE NEEDLE MECHANISM TO FIRE AND DEPLOY THE CANNULA OR TO DETERMINE ITS ROOT CAUSE. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE REACHED 371 MG/DL LESS THAN 24 HOURS AFTER THE POD WAS ACTIVATED. HE TAPPED THE POD AND THEN HE NOTICED THE NEEDLE FINALLY SHOT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577242 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L41141

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR