BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4213650 · Received September 26, 2014

    Report

    Report Number
    3004464228-2014-01448
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 30, 2014
    Report Date
    August 30, 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 BENT CANNULA OR TO DETERMINE WHETHER IT CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. 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 OVER 250 MG/DL (EXACT BG WAS NOT PROVIDED) LESS THAN 36 HOURS AFTER THE POD WAS ACTIVATED. HE NOTICED THERE WAS INSULIN LEAKING DURING A BOLUS DELIVERY AND UPON INSPECTION HE REALIZED THE CANNULA WAS A LITTLE BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599996 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40807

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR