BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2842666 · Received November 21, 2012

    Report

    Report Number
    2531779-2012-13847
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 30, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4): A TIMEKEEPING ACCURACY TEST WAS PERFORMED; AFTER SETTING THE TIME AND DATE THE BATTERY WAS REMOVED. THE PUMP WAS LEFT WITHOUT POWER FOR 1 HOUR; WHEN THE PUMP WAS POWERED ON IT HAD RETURNED TO THE DEFAULT TIME AND DATE. THE PUMP WAS OPENED AND THE INTERNAL BATTERY WAS FOUND TO BE LEAKING. TESTING WAS UNABLE TO COMPLETE TIMEKEEPING TEST DUE TO BATTERY ISSUE. NO ACTIVITY RELATED TO THE COMPLAINT WAS OBSERVED IN THE BLACK BOX OR SUSPEND HISTORY. NO DATA IN THE SUSPENDED HISTORY OR BLACK BOX FROM THE TIME OF THE REPORTED HISTORY ISSUE DUE TO CONTINUED USE.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS FOR AN UNRELATED ISSUE AND DURING TROUBLESHOOTING IT WAS NOTED THAT THE HISTORY CONTAINED DATE FOR (B)(6), 2007. THE PATIENT DENIED ANY POWER LOSS AND CONFIRMED THAT THE TIME AND DATE HOLDS 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
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR