BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1945378 · Received December 28, 2010

    Report

    Report Number
    3004464228-2010-01454
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    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 INVESTIGATION RESULTS OF THE RETURNED PDM FOUND EVIDENCE OF CONTAMINATION OR PARTICULATE MATTER ON THE CONTACT SURFACES OF SENSORS WITHIN THE BG METER PORT. THE PRESENCE OF THIS DEBRIS CAN CAUSE INTERFERENCE WITH THE FUNCTIONALITY OF THE METER, POTENTIALLY RESULTING IN ERRONEOUS BG READINGS. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE CHECKED HIS BG LEVELS WITH A BACK-UP METER, WHICH READ "LOW" (SPECIFIC BG LEVELS WERE NOT PROVIDED). HE THEN CHECKED HIS LEVELS WITH THE PDM, WHICH READ 101 MG/DL. THE REPORT THEN INDICATED THAT "HE TREATED HIMSELF FOR A LOW BG". (NOTE: IT IS UNKNOWN WHAT THE CUSTOMER'S TARGET BG LEVELS ARE.) THE CUSTOMER REPORTED THAT HIS BG LEVELS "WERE SO LOW" THAT HE "WAS PASSING OUT". HE INDICATED THAT HE HAD PERFORMED A "BG SOLUTION" TEST AND RESULTS WERE "INCORRECT" - THEY WERE REPORTEDLY OFF BY FIVE POINTS. 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 L12073

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other