BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242173 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11666
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/24/2013 DEVICE EVALUATION:THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/15/2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE BATTERY WAS NOT RETURNED WITH THE PUMP. THE PUMP BOOTED TO THE VERIFY SCREEN WITH VIBRATORY AND AUDIBLE SOUNDS. THE BLACK BOX SHOWS UNUSUAL FLUCTUATION OF THE VOLTAGE ON 06/26/2013. THE PUMP WAS TESTED WITH AN EXTERNAL POWER SUPPLY AND IDLE, SLEEP, REWIND AND LOAD CURRENTS ALL WERE FOUND TO BE WITHIN REQUIRED SPECIFICATIONS. THERE WAS NO OVERHEATING WAS DUPLICATED DURING TESTING. THE PUMP COVER WAS REMOVED AND NO EVIDENCE OF LOOSE COMPONENTS OR MOISTURE CONTAMINATION WAS OBSERVED INSIDE THE PUMP. THE TEMPERATURE ISSUE WAS OBSERVED IN THE HISTORY BUT COULD NOT BE DUPLICATED DURING THE INVESTIGATION. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A TEMPERATURE (TEMPERATURE ISSUE) 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
    342549 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR