BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3172464 · Received June 17, 2013

    Report

    Report Number
    2531779-2013-08279
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE KEYPAD COVER WAS MISSING AND KEYPAD FLEX TOTALLY WAS DAMAGED / RIP OFF. AUDIO BOLUS BUTTON COVER IS INTACT TO THE PUMP. THE PUMP HAD A DIM, PINK DISPLAY SCREEN. THE DISPLAY LENS WAS FOUND TO BE CRACKED AROUND THE PERIMETER OF THE BEZEL. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY WAS FOUND TO BE DIM. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274067 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR