BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3944779 · Received July 18, 2014

    Report

    Report Number
    2531779-2014-20708
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/21/2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH VISIBLE EVIDENCE OF MOISTURE BEHIND THE DISPLAY LENS. DURING TESTING, THE PUMP POWERED ON TO A BLANK DISPLAY SCREEN WITH FUNCTIONING AUDITORY AND VIBRATORY SETTINGS. THE PUMP HISTORIES COULD NOT BE DOWNLOADED. A LEAK TEST WAS PERFORMED AND FAILED DUE TO UNRELATED DAMAGE TO THE PUMP CASING. THE PUMP WAS OPENED AND INTERNAL MOISTURE WAS OBSERVED INSIDE THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN W/MOISTURE) ISSUE. THE REPORTER ALLEGED THAT THERE WAS EVIDENCE OF MOISTURE BEHIND THE DISPLAY. 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
    422860 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR