BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2971935 · Received January 18, 2013

    Report

    Report Number
    3004464228-2013-00056
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 23, 2012
    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 DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE BENT CONDITION OF THE CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. NO PRODUCT LOT NUMBER WAS REPORTED THEREFORE NO QUALIFICATION RECORD REVIEW COULD BE PERFORMED. THE OMNIPOD 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," AND ADVISES "TO AVOID HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) CHECK YOUR BLOOD GLUCOSE AT LEAST 4-6 TIMES A DAY (WHEN YOU WAKE UP, BEFORE EACH MEAL, AND BEFORE GOING TO BED)."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2012 AT WORK, SHE FELT SICK AND NAUSEATED. HER BLOOD GLUCOSE MEASURED 448 MG/DL, SO SHE CORRECTED WITH A 3.6 UNIT INSULIN BOLUS. AT 50 MINUTES LATER, HER BG WAS 453 MG/DL. SHE DEACTIVATED THE POD, OBSERVED THAT THE CANNULA WAS BENT, AND DISCARDED THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28739 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR