BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4140372 · Received October 3, 2014

    Report

    Report Number
    2531779-2014-28322
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/27/2014 WITH THE FOLLOWING FINDINGS: A MANUAL TIME CHANGE FROM 9:33AM TO 10:33AM WAS OBSERVED ON (B)(6) 2014. THERE WAS NO OTHER ACTIVITY RELATED TO THE COMPLAINT OBSERVED IN THE PUMP HISTORIES. A TIMEKEEPING ACCURACY TEST WAS PERFORMED. THE PUMP MAINTAINED TIME ACCURATELY DURING A 5 DAY DURATION TEST; HOWEVER WHEN THE PUMP WAS LEFT WITHOUT POWER FOR 1 HOUR AND THEN POWERED BACK ON, IT HAD RETURNED TO THE DEFAULT TIME AND DATE. THE PUMP WAS OPENED FOR FURTHER INVESTIGATION AND THE INTERNAL CLOCK BATTERY WAS FOUND TO HAVE MALFUNCTIONED.

    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 A HISTORY/SETTINGS (TIME LOSS/GAIN) ISSUE. THE REPORTER STATED THAT THERE HAD BEEN GREATER THAN 5 MINUTES/MONTH RELATED TO A TIME LOSS/GAIN ISSUE IN THE PUMP. 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
    618614 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR