BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3952480 · Received July 23, 2014

    Report

    Report Number
    2531779-2014-21079
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    July 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 09/03/2014 WITH THE FOLLOWING FINDINGS: THE PRIMARY COMPLAINT, OF A BLANK-DISPLAY ISSUE, COULD NOT BE INVESTIGATED DUE TO A NO-POWER ISSUE, THUS NO CONCLUSIONS COULD BE DETERMINED IN THIS REGARD. VISUAL INSPECTION REVEALED THAT THERE WAS MOISTURE BEHIND THE DISPLAY LENS. THE PUMP FAILED A LEAK TEST DUE TO A DISPLAY LENS LEAK. THE PUMP FAILED TO POWER ON AND THE PUMP HISTORY AND BLACK BOX DATA COULD NOT BE DOWNLOADED DUE TO MOISTURE DAMAGE. THE PUMP CASE WAS REMOVED, AND EVIDENCE OF MOISTURE AND CORROSION WAS OBSERVED ON ALL OF THE INTERNAL SURFACES.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN W/MOISTURE) ISSUE. ALLEGEDLY, MOISTURE WAS EVIDENT BEHIND THE DISPLAY SCREEN. 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
    430648 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR