BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3980358 · Received August 5, 2014

    Report

    Report Number
    2531779-2014-22408
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 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 (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP HISTORY WAS REVIEWED AND NO EVIDENCE OF A SHORT BATTERY LIFE ISSUE WAS OBSERVED. THE BATTERY VOLTAGES IN THE BLACK BOX WERE WITHIN NORMAL SPECIFICATIONS. TYPICAL USAGE ALARMS WERE OBSERVED IN THE PUMP'S ALARM HISTORY. AN EXTERNAL POWER SUPPLY WAS USED TO TEST THE IDLE, SLEEP, REWIND AND LOAD CURRENTS, AND ALL WERE FOUND TO BE WITHIN SPECIFICATION. NO INTERMITTENT CONNECTIONS OR MOISTURE DAMAGE WAS OBSERVED INSIDE THE PUMP WHEN THE COVER WAS REMOVED FOR INVESTIGATION. THE ALLEGED COMPLAINT COULD NOT BE DUPLICATED. THE BATTERY CAP WAS NOT RETURNED, SO A TEST CAP WAS USED TO COMPLETE ALL TESTING.

    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 THAT THE PUMP WAS EXPERIENCING SHORTER THAN EXPECTED BATTERY LIFE. 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
    457123 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR