BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6726530 · Received July 19, 2017

    Report

    Report Number
    2531779-2017-15349
    Event Type
    Malfunction
    Date Received
    July 19, 2017
    Report Date
    June 23, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/23/2017 WITH THE FOLLOWING FINDINGS: A DIM DISPLAY SCREEN THAT ALSO HAD RED HUE. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DISPLAY WITH DIM/FADING/COLOR SPECTRUM ISSUE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 06/23/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505435 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR