BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1845034 · Received September 13, 2010

    Report

    Report Number
    3004464228-2010-01270
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 2010
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION RESULTS OF THE RETURNED PDM FOUND EVIDENCE OF "DEBRIS" WITHIN THE BG METER PORT. THOUGH THE BG METER FUNCTIONED AS INTENDED DURING THE EVALUATION, THE PRESENCE OF THE DEBRIS HAD THE POTENTIAL TO AFFECT THE FUNCTIONALITY OF THE METER, POSSIBLY RESULTING IN THE LOW BG READINGS AS REPORTED. THE PRESENCE OF DEBRIS IN THE BG METER PORT IS THE RESULT OF USER NEGLIGENCE IN PROPERLY CARING FOR THE PDM AND IS IN NO WAY REFLECTIVE OF ANY MANUFACTURING OR PRODUCT RELATED ISSUE. IT SHOULD BE NOTED THAT THE PDM'S BG METER WAS THOROUGHLY EVALUATED - THERE IS NO EVIDENCE OF ANY MALFUNCTION OR PRODUCT CONDITION THAT COULD HAVE CAUSED OR CONTRIBUTED TO ERRONEOUS OR LOW BG READINGS. ALL TEST READINGS WERE FOUND TO BE WITHIN THE SPECIFIED TOLERANCE LIMIT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PDM HAS BEEN DISPLAYING "INCORRECT READINGS"; SHE HAS BEEN RECEIVING "LOW READINGS", THOUGH NO SPECIFIC BG LEVELS WERE PROVIDED (LEVELS ARE ASSUMED TO BE BELOW 70 MG/DL). IN ADDITION, SHE STATED THAT THE PDM HAS BEEN INITIATING "A LOT OF METER ERRORS". THE PDM WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 13100-2B L12032

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other