BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3926408 · Received July 10, 2014

    Report

    Report Number
    2531779-2014-19532
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/30/2014 WITH THE FOLLOWING FINDINGS: KEYPAD COVER IS PEELING OFF THE BASE. ALL KEYPAD BUTTONS RESPOND NORMALLY. THE DISPLAY IS DIM/FADING/REDDISH. THE KEYPAD COVER WAS REMOVED AND NO CONTAMINATION WAS FOUND UNDER CONTACTS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED DISPLAY IS DIM/FADING/REDDISH. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 06/30/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403989 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR