BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3200155 · Received July 1, 2013

    Report

    Report Number
    2531779-2013-09395
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/07/2014 WITH THE FOLLOWING FINDINGS: THERE WAS NO DATA AVAILABLE IN THE PUMP¿S HISTORY FROM THE TIME OF THE REPORTED EVENT, DUE TO CONTINUED USE OF THE PUMP. THE AVAILABLE HISTORY SHOWED NO ACTIVITY RELATED TO THE COMPLAINT. A TIMEKEEPING ACCURACY TEST WAS PERFORMED; THE PUMP WAS KEEPING TIME ACCURATELY. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (TIME/DATE ISSUE) ISSUE. THE REPORTER STATED THAT THE TIME AND DATE HAD RESET AND COULD NOT CONFIRM IF THIS ISSUE OCCURRED WITH BATTERY CHANGES. 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
    299538 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR