BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3951077 · Received July 22, 2014

    Report

    Report Number
    2531779-2014-20998
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION AND DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON 07/15/2014 WITH THE FOLLOWING FINDINGS: UNEXPLAINED POWER ON RESETS OBSERVED IN THE BLACK BOX. NO DAMAGE FOUND TO THE BATTERY COMPARTMENT. RETURNED BATTERY CAP HAS STRIPPED THREADS AND IS UNABLE TO FULLY SECURE TO THE PUMP; POWER ON RESETS DUPLICATED WITH RETURNED BATTERY CAP. A NEW TEST BATTERY CAP WAS ABLE TO FULLY ATTACH TO THE PUMP WITH NO YELLOW O RING SHOWING. A 24HR DURATION TEST WAS COMPLETED USING THE NEW TEST BATTERY CAP; NO POWER INTERRUPTIONS WERE DUPLICATED. REMOVAL OF THE PUMP COVER SHOWED NO EVIDENCE OF INTERNAL MOISTURE. NO DAMAGE TO THE POWER CIRCUIT WAS OBSERVED.

    Description of Event or Problem · 1

    THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED A DAMAGED BATTERY CAP. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON 07/15/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428273 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR