BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4232628 · Received November 6, 2014

    Report

    Report Number
    2531779-2014-31764
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 17, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, IT WAS REPORTED TO ANIMAS THAT A TIME/DATE RESET ISSUE HAD OCCURRED IN THE PUMP. NO ADDITIONAL INFORMATION WAS AVAILABLE. THERE WAS NO INFORMATION AVAILABLE REGARDING ANY ADVERSE EVENTS ASSOCIATED WITH THIS ISSUE. TROUBLESHOOTING COULD NOT BE FULLY COMPLETED AT THE TIME OF THE ALLEGED COMPLAINT. THE PUMP WAS NOT AVAILABLE FOR RETURN AND CUSTOMER TECHNICAL SUPPORT HAS FOLLOWED DUE DILIGENCE PROCEDURES TO GAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715271 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR