BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3233176 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11227
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/25/2013 WITH THE FOLLOWING FINDINGS: THE DISPLAY SCREEN WAS DIM AND THE LETTERS HAD A RED HUE ON THE HIGHEST CONTRAST SETTING. THE DIM SCREEN WAS REPLACED WITH A NEW TEST DISPLAY AND FUNCTIONED PROPERLY. UNRELATED TO THE INITIAL COMPLAINT A CRACK WAS OBSERVED IN THE PUMP CASE NEAR THE TOP RIGHT CORNER OF DISPLAY. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DISPLAY ISSUE) ISSUE. IT WAS REPORTED THAT THE DISPLAY WAS CLOUDY, AND THERE WAS MOISTURE BEHIND THE SCREEN. THERE WAS A BIG BLACK DOT AT THE BOTTOM OF THE SCREEN, AND IT WAS SPREADING. BATTERY WAS CHANGED, BUT IT DID NOT RESOLVE THE ISSUE. 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
    334377 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR