BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4612635 · Received August 12, 2014

    Report

    Report Number
    1052693-2015-00098
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    January 15, 2015
    Report Date
    February 3, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    LFR
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER AND TEST STRIP EVALUATION RESULTED IN NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAS HIGH GLUCOSE VALUE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT OF "HIGH" BLOOD RESULT. RECALLED THE LAST 5 BLOOD RESULTS FROM METER MEMORY: (DATE IS INCORRECT) (B)(6) 2014 - 6:38 AM - 441 MG/DL; (B)(6) 2014 - 8:46 PM - HI; (B)(6) 2014 - 8:44 PM - HI; (B)(6) 2014 - 8:44 PM - HI; (B)(6) 2014 - 8:43 PM - HI. PERFORMED A BACK TO BACK BLOOD TEST USING CAPILLARY BLOOD SAMPLE AND THE RESULTS WERE 85 MG/DL AND 78 MG/DL. EXPECTED RESULT IS 120 MG/DL AND 160 MG/DL FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481138 TRUERESULT BLOOD GLUCOSE SYSTEM LFR NIPRO DIAGNOSTICS, INC. TRUERESULT PR2050

    Patients

    Seq Age Sex Outcome Treatment
    1