BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3191393 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09051
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON JUNE 20, 2013 WITH THE FOLLOWING FINDINGS. THE DISPLAY WAS FOUND TO BE DIM AND REDDISH. A TEST-SCREEN WAS INSTALLED AND NO PROBLEMS WERE FOUND WITH PRINTED CIRCUIT BOARD.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS TO REPORT THE PUMP DISPLAY WAS DIM/FADING ON A GRADUAL BASIS. THE PATIENT NOTED THERE HAD BEEN NO TRAUMA TO THE PUMP, NO MOISTURE EXPOSURE AND NO POWER LOSS. THE ISSUE WAS NOT RESOLVED. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291251 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR