BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3930452 · Received July 11, 2014

    Report

    Report Number
    2531779-2014-19808
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Report Date
    July 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/19/2014 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE TORN. EVALUATION REVEALED THAT CONTRAST, UP, AND DOWN KEYPAD BUTTONS WERE UNRESPONSIVE. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER THE OK, DOWN, AND UP KEY CONTACTS. THERE WAS NO EVIDENCE OF MOISTURE ON THE PUMP¿S INTERNAL COMPONENTS. UNRELATED TO THE COMPLAINT, A BATTERY COMPARTMENT CRACK WAS DISCOVERED. MOISTURE WAS OBSERVED WITHIN THE BATTERY COMPARTMENT. LEAK TESTING REVEALED A BATTERY COMPARTMENT LEAK. INVESTIGATION REVEALED THE DISPLAY SCREEN WAS DIM AND DISCOLORED.

    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 ALL KEYPAD BUTTONS WERE UNDER-RESPONSIVE. 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
    408242 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR