BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2070183 · Received April 27, 2011

    Report

    Report Number
    2531779-2011-02910
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: 10/2009. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. INVESTIGATION REVEALED THAT THE AUDIO BOLUS BUTTON COVER IS PEELING. EVALUATION CONFIRMED THAT THE AUDIO BOLUS BUTTON IS DIFFICULT TO PRESS. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER THE AUDIO BOLUS BUTTON KEY CONTACT. TESTING REVEALED THAT ALL KEYPAD BUTTONS ARE RESPONDING APPROPRIATELY.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE AUDIO BOLUS BUTTON REQUIRES EXCESSIVE FORCE TO OBTAIN A RESPONSE. HE NOTED THAT THE ISSUE BEGAN 2 WEEKS AGO, AND THE AUDIO BOLUS BUTTON COVER CAME OFF TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR