BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3972605 · Received August 1, 2014

    Report

    Report Number
    2531779-2014-22033
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 26, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 09/10/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE AUDIO BOLUS BUTTON COVER WAS MISSING, THUS THE BUTTON WAS DYSFUNCTIONAL; THE REPORTED EVENT WAS DUPLICATED. THE PUMP FAILED A LEAK TEST DUE TO AN AUDIO BOLUS BUTTON LEAK. THE PUMP CASE WAS REMOVED, AND EVIDENCE OF CORROSION WAS OBSERVED ON INTERNAL COMPONENTS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    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 UNDER RESPONSIVE. REPORTEDLY, THE AUDIO BOLUS BUTTON COVER WAS MISSING/PEELING; MOISTURE/CORROSION WAS REPORTED TO BE EVIDENT IN THE AUDIO BOLUS BUTTON AREA. 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
    450478 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR