BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4093044 · Received September 10, 2014

    Report

    Report Number
    3004464228-2014-01338
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    July 6, 2014
    Report Date
    August 12, 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'S MOTHER REPORTED ON (B)(6) 2014 AT 7:00 AM HER SON ACTIVATED A NEW POD AND HIS BLOOD GLUCOSE REACHED 415 MG/DL LESS THAN 4 HOURS AFTER THE POD WAS ACTIVATED. SHE ALSO STATED THAT SHE MAY HAVE GIVEN HIM A MANUAL INJECTION OF INSULIN (EXACT DOSAGE WAS NOT PROVIDED) BUT WAS NOT SURE. THE CANNULA WAS BENT BUT SHE FEELS LIKE IT WAS DUE TO THE POD BEING WRAPPED UP IN THE ADHESIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559660 OMNIPOD INSULIN PUMP PUMP, INFUSION, INULIN LZG INSULET CORPORATION 14000 L41004

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR