BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1893860 · Received November 2, 2010

    Report

    Report Number
    3004464228-2010-01348
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    June 24, 2010
    Report Date
    October 6, 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. THIS HAD THE POTENTIAL TO AFFECT THE FUNCTIONALITY OF THE METER, POSSIBLY RESULTING IN ERRONEOUS BG READINGS. 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 MFG OR PRODUCT RELATED ISSUE. IT SHOULD BE NOTED THAT THE INVESTIGATION FOUND NO EVIDENCE OF ANY MALFUNCTION THAT COULD HAVE CAUSED OR CONTRIBUTED TO ERRONEOUS BG READINGS. THE RESULTS OF ALL BG READING TEST WERE FOUND TO BE WITHIN THE SPECIFIED TOLERANCE LIMITS. THE REPORTED DISCREPANT BG READINGS ARE CONSIDERED TO HAVE BEEN CAUSED BY THE PRESENCE OF DEBRIS WITHIN THE BG METER AND NOT BY ANY MFG OR PRODUCT RELATED ISSUE. NOTE: A REVIEW OF THE PDM'S HISTORY CONCLUDED THAT THE CUSTOMER'S REPORT COULD NOT BE VERIFIED. THE CUSTOMER REPORTED THAT THE DISCREPANT BG READINGS OCCURRED ON (B)(6) 2010, YET DATA WAS AVAILABLE ONLY AS FAR BACK AS (B)(6) 2010.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PDM WAS GIVING FLUCTUATION BG READINGS. THREE READINGS WERE TAKEN "RIGHT AFTER EACH OTHER"; THE RESULTS IN SUCCESSION WERE "HIGH" (GREATER THAN 500 MG/DL), 50 MG/DL AND 250 MG/DL. INSULET CUSTOMER SUPPORT RECOMMENDED THAT SHE TRY TESTING AGAIN WITH A NEW VIAL OF TEST STRIPS. THE PDM WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11360 L11807

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other