BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3822359 · Received May 20, 2014

    Report

    Report Number
    2531779-2014-14260
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH A WORN KEYPAD COVER. DURING TESTING, THE OK AND DOWN ARROW KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER THE CONTRAST AND DOWN ARROW KEYPAD BUTTON CONTACTS. UNRELATED TO THE INITIAL COMPLAINT, THE DISPLAY SCREEN WAS DIM AND DISCOLORED WITH A LINE THROUGH THE MIDDLE OF THE DISPLAY SCREEN. 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.

    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 THE KEYPAD BUTTONS WERE UNDER-RESPONSIVE. NO ADDITIONAL INFORMATION WAS PROVIDED AND TROUBLESHOOTING WAS UNABLE TO BE COMPLETED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE REMAINED RESOLVED. 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
    298800 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR