BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3900188 · Received June 27, 2014

    Report

    Report Number
    2531779-2014-18555
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE PUMP POWERED ON TO A BLANK DISPLAY AND FUNCTIONING AUDIBLE AND VIBRATORY SETTINGS. UNRELATED TO THE INITIAL COMPLAINT, THE DISPLAY SCREEN WAS CRACKED, AND ALL OF THE BUTTONS WERE UNABLE TO BE TESTED. THE TEST DISPLAY SCREEN WAS USED, AND THE DISPLAY SCREEN FUNCTIONED PROPERLY.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. THE REPORTER ALLEGED THAT THE DISPLAY WAS BLANK. IT WAS NOTED THAT THE PUMP'S AUDIO TONES AND VIBRATIONS WERE FUNCTIONAL. 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
    377181 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR