BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3003380 · Received February 13, 2013

    Report

    Report Number
    3004464228-2013-00120
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    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 BENT OR KINKED CANNULA, OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE RECORDS USER GUIDE WARNS "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER."

    Description of Event or Problem · 1

    THE CUSTOMER'S POD WAS ACTIVATED ON (B)(6) IN THE EVENING, AND SHE HAD NORMAL BLOOD GLUCOSE RESULTS THROUGH 8:00AM ON (B)(6), WHEN IT WAS 125 MG/DL. AT 12:00PM, IT WAS 363 MG/DL AND SHE TOOK A 3.90 UNIT BOLUS. AT 2:49PM, HER BLOOD GLUCOSE WAS 413 MG/DL. AT 2:53PM, SHE TOOK A 2.65 UNIT BOLUS. AT 3:38PM, HER BLOOD GLUCOSE WAS 366 MG/DL. SHE DEACTIVATED THE POD AT 3:39PM, AND WHEN IT WAS REMOVED, THE CANNULA LOOKED BENT OR KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63894 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30953

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR