BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3944530 · Received July 18, 2014

    Report

    Report Number
    2531779-2014-20682
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    July 13, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 08/20/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THERE WAS MOISTURE BEHIND THE DISPLAY LENS. THE PUMP POWERED ON PROPERLY, AS CONFIRMED BY THE PRESENCE OF THE AUDITORY CUE, BUT THE DISPLAY SCREEN WAS BLANK. THE VIBRATORY CUE THAT ACCOMPANIES POWER-ON WAS NOT PRESENT DUE TO INTERNAL MOISTURE DAMAGE. THE PUMP FAILED A LEAK TEST DUE TO A LEAK AT THE DISPLAY LENS. THE PUMP CASE WAS REMOVED, AND EVIDENCE OF CORROSION WAS OBSERVED ON INTERNAL COMPONENTS, INCLUDING COMPONENTS INVOLVED IN DISPLAY FUNCTIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) 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
    423301 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR