BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3132989 · Received May 29, 2013

    Report

    Report Number
    2531779-2013-07145
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 3, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED 07/24/2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: CONFIRMED THE TEXT ON THE DISPLAY SCREEN IS DIM/FADED AND THE TEXT IS DISCOLORED UPON START UP AND DIFFICULT TO READ. REPLACED FADED DISPLAY WITH TEST DISPLAY. THE TEST SCREEN IS FULLY FUNCTIONAL AND IS FULLY ILLUMINATED WITH NO VISIBLE SIGNS OF FADING OR DISCOLORATION OF TEXT.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. IT WAS REPORTED THAT THE DISPLAY WAS DIM AND VERY DIFFICULT TO READ. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. 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
    235764 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR