BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3761130 · Received December 31, 2013

    Report

    Report Number
    3004464228-2013-01626
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Date of Event
    October 18, 2013
    Report Date
    December 3, 2013
    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 EVAL. WE ARE UNABLE TO CONFIRM THE REPORTED FAILURE OF THE NEEDLE MECHANISM TO FIRE AND DEPLOY THE CANNULA OR TO DETERMINE ITS ROOT CAUSE. NO PRODUCT LOT NUMBER WAS REPORTED THEREFORE NO QUALIFICATION RECORDS WERE REVIEWED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HER BLOOD GLUCOSE REACHED OVER 500 MG/DL LESS THAN 24 HOURS AFTER THE POD WAS ACTIVATED. SHE GAVE HERSELF A COUPLE OF MANUAL INJECTIONS OF INSULIN (EXACT DOSAGE WAS NOT PROVIDED). THE POD WAS DEACTIVATED AND SHE NOTICED THE NEEDLE DID NOT DEPLOY THE CANNULA INTO THE INFUSION SITE. SHE COULD SMELL INSULIN AND THERE WAS ALSO BLOOD NOTED AT THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682949 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR