BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3794861 · Received May 6, 2014

    Report

    Report Number
    2531779-2014-12677
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Report Date
    April 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: EVALUATION CONFIRMED THE TEXT ON THE DISPLAY SCREEN IS DIM/FADED AND DISCOLORED. INVESTIGATORS OBSERVED INTERMITTENT RESPONSES TO BUTTON PRESSES ON THE 'UP' AND 'CONTRAST' BUTTONS. MULTIPLE BUTTON PRESSES WITH INCREASED FORCE APPLIED ARE REQUIRED BEFORE THE 'UP' AND 'CONTRAST' BUTTONS ENGAGE. MULTIPLE BUTTON PRESSES WITH INCREASED FORCE APPLIED ARE REQUIRED BEFORE THE 'UP' AND 'CONTRAST' BUTTONS ENGAGE. EVALUATION REVEALED THAT THERE WAS CONTAMINATION WAS PRESENT UNDER THE CONTACTS OF ALL BUTTONS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) 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
    270019 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR