BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1950973 · Received January 3, 2011

    Report

    Report Number
    3004464228-2010-01475
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 1, 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 DUST AND DEBRIS WITHIN THE BG METER PORT. THIS HAD THE POTENTIAL TO AFFECT THE FUNCTIONALITY OF THE METER, POSSIBLY RESULTING IN "ERRATIC" BG READINGS, AS REPORTED. THE PRESENCE OF DEBRIS IN THE BG METER PORT IS IN NO WAY REFLECTIVE OF ANY MANUFACTURING 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 ERRATIC BG READINGS ARE CONSIDERED TO HAVE BEEN CAUSED BY THE PRESENCE OF DEBRIS WITHIN THE BG METER AND NOT BY ANY MANUFACTURING OR PRODUCT RELATED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PDM HAS BEEN "SHOWING ERRATIC READINGS" FOR OVER THE PAST MONTH. AS AN EXAMPLE, THE PDM WILL "READ 400MG/DL AND A MINUTE LATER, IT WILL SHOW 100MG/DL." THIS HAS BEEN OCCURRING MORE FREQUENTLY AND HE THEREFORE, "DOESN'T TRUST THE PDM ANYMORE." THE DEVICE 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 11360 L12023

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other