BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3181598 · Received June 21, 2013

    Report

    Report Number
    2531779-2013-08717
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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 DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 07/24/2013 WITH THE FOLLOWING RESULTS: TESTING CONFIRMED A TIME/DATE ISSUE: A TIMEKEEPING ACCURACY TEST WAS PERFORMED AND THE PUMP MAINTAINED TIME ACCURATELY DURING 5 DAY DURATION TEST; HOWEVER WHEN PUMP WAS LEFT WITHOUT POWER FOR 1 HOUR AND THEN POWERED BACK ON, IT HAD RESET TO THE DEFAULT TIME AND DATE. THE PUMP WAS OPENED AND THE INTERNAL BATTERY WAS FOUND TO BE LEAKING. 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) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (TIME/DATE ISSUE) ISSUE. THE REPORTER STATED THAT THE PUMP'S TIME AND DATE HAD RESET TO FACTORY DEFAULT AT RANDOM. THE REPORTER COULD NOT CONFIRM WHETHER OR NOT THIS OCCURRED WITH A BATTERY CHANGE. 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
    281995 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR