BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3093545 · Received May 6, 2013

    Report

    Report Number
    2531779-2013-05893
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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 TEXT ON THE DISPLAY SCREEN IS DIM FADED AND DISCOLORED UPON START UP AND DIFFICULT TO READ. THE DISPLAY LENS IS HEAVILY SCRATCHED AND DIFFICULT TO READ. EVALUATION WAS COMPLETED WITH A TEST DISPLAY SCREEN, THE TEST SCREEN IS FULLY FUNCTIONAL AND FULLY ILLUMINATED WITH NO VISIBLE SIGNS OF FADING. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE KEYPAD SYMBOLS WERE WORN, WHICH HAS NO EFFECT ON INSULIN DELIVERY. (B)(6). DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RE/CORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND SCRATCHED. 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
    197246 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR