BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3951746 · Received July 23, 2014

    Report

    Report Number
    2531779-2014-21036
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    July 9, 2014
    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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE DISPLAY LENS HAS PERIMETER CRACKS AND SCRATCHES WITH NO LENS FILM. THE KEYPAD IS WORN. THE BATTERY CAP THAT CAME WITH UNIT HAS THE THREADS WORN OFF; IT WILL NOT SECURE TO PUMP. USED TEST CAP FOR TESTING PURPOSES. THE KEYPAD SYMBOL FOR DOWN HAS BEEN WORN AWAY AND THE OTHERS ARE WEARING AWAY. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED DISPLAY LENS HAS PERIMETER CRACKS AND THE BATTERY CAP THREADS WERE WORN OFF. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430950 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR