BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3933801 · Received July 15, 2014

    Report

    Report Number
    2531779-2014-20010
    Event Type
    Malfunction
    Date Received
    July 15, 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
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/05/2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH A TORN AUDIO BOLUS BUTTON COVER, AND THE BOLUS BUTTON COULD NOT BE TESTED. DURING TESTING, THE BOLUS BUTTON COVER WAS REMOVED AND MOISTURE WAS FOUND ON THE BUTTON CONTACT. THERE WAS VISIBLE EVIDENCE OF MOISTURE BEHIND THE DISPLAY SCREEN; AND THE LEAK TEST FAILED DUE TO A DISPLAY LENS LEAK. THE PUMP WAS OPENED AND MOISTURE WAS FOUND ON ALL INTERNAL SURFACES OF THE PUMP.

    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 BUTTON/KEYPAD (ABB DMG PRIOR TCTL CNG W/MOIST) ISSUE. THE REPORTER ALLEGED THAT THE AUDIO BOLUS BUTTON WAS UNRESPONSIVE. ALSO, THE AUDIO BOLUS BUTTON WAS REPORTEDLY TORN/PUNCTURED. FURTHERMORE, MOISTURE WAS EVIDENT BEHIND THE 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
    412477 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR