BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2031790 · Received March 21, 2011

    Report

    Report Number
    2531779-2011-01740
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. DURING INVESTIGATION, IT WAS FOUND THAT THE KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS. UNRELATED TO THE COMPLAINT, DURING EVALUATION, IT WAS ALSO OBSERVED THAT THE DISPLAY HAD A REDDISH TINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD IS NOT RESPONDING APPROPRIATELY. IT WAS REPORTED THAT THE PUMP IS NOT EXPOSED TO MOISTURE AND THE KEYPAD AND PUMP ARE INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1