BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3234131 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11314
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/17/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S HISTORY SHOWED TWO UNEXPLAINED REBOOTS. NO DAMAGE WAS FOUND TO THE BATTERY COMPARTMENT. THE RETURNED BATTERY CAP WAS FOUND TO BE WITHIN SPECIFICATIONS AND FIT SECURELY TO THE PUMP. DURING TESTING, THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ANY ALARMS OR POWER LOSS. THE PUMP COVER WAS REMOVED AND NO DAMAGE WAS FOUND TO THE INTERNAL COMPONENTS.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE PATIENT REPORTED THE PUMP HAS BEEN SELF REBOOTING, LAST NIGHT BEING THE LAST TIME. THE PATIENT STATES THE CAP AND PUMP HAVE NO DAMAGE AND ARE SECURE. THE PATIENT USED THE PUMP IN WATER WITH NO WATER NOTED 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
    335457 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR