BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4112837 · Received September 24, 2014

    Report

    Report Number
    2531779-2014-27201
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Report Date
    September 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 12/08/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/19/2014 WITH THE FOLLOWING FINDINGS: THE PUMP'S BLACK BOX SHOWED THE FOLLOWING ACTIVITY: THE TIME/DATE RESET TO DEFAULT FOLLOWING A PUMP REBOOT EVENT AT 6:35PM 7/8/14; THE TIME WAS THEN MANUALLY SET TO 8:23AM 9/10/14. THERE WERE MANUAL TIME CHANGES FROM 9:18AM 9/10/14 TO 12:31PM 7/8/14 AND FROM 12:34PM 7/8/14 TO 9:25AM 9/10/14. A TIMEKEEPING ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE KEEPING TIME ACCURATELY.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (TIME LOSS/GAIN) ISSUE. 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
    595583 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR