BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3932327 · Received July 14, 2014

    Report

    Report Number
    2531779-2014-19906
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    July 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/14/2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH VISIBLE EVIDENCE OF MOISTURE BEHIND THE DISPLAY SCREEN. DURING TESTING, THE PUMP POWERED ON TO A DISTORTED AND CLOUDY DISPLAY SCREEN. THE PUMP FAILED THE LEAK TEST DUE TO A DISPLAY SCREEN LEAK. THE PUMP WAS OPENED AND MOISTURE CORROSION WAS OBSERVED INTERNALLY.

    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 (CLOUDY W/ MOISTURE) ISSUE. REPORTEDLY, THE DISPLAY WAS CLOUDY AND MOISTURE WAS OBSERVED BEHIND THE DISPLAY. THE REPORTER STATED THAT THE SCREENS CAN BE READ/MANEUVER SAFELY. 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
    410512 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR