BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4222293 · Received November 3, 2014

    Report

    Report Number
    2531779-2014-31359
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 20, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/20/2014 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE PUMP WAS POWERED ON AND THE DISPLAY SCREEN APPEARED DIM AND DISCOLORED. UNRELATED TO THE DISPLAY ISSUE, THE KEYPAD COVER WAS PEELING AT THE OK AND DOWN ARROW BUTTONS. ALL OF THE KEYPAD BUTTONS RESPONDED PROPERLY TO USER PRESSES. (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM AND DISCOLORED DISPLAY. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 10/20/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702609 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR