BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4122510 · Received September 22, 2014

    Report

    Report Number
    1052693-2014-00361
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    August 29, 2014
    Report Date
    December 17, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION:USER'S MISUNDERSTANDING OF ERRATIC RESULTS.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ERRATIC BLOOD RESULTS. BACK TO BACK BLOOD TESTS PERFORMED A THE TIME OF THE CALL RESULTED IN 172 MG/DL AND 165MG/DL. LAST 4 RESULTS IN MEMORY WERE 169MG/DL, 254MG/DL, 144MG/DL AND 140MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ERRATIC BLOOD RESULTS. BACK TO BACK BLOOD TESTS PERFORMED AT THE TIME OF THE CALL RESULTED IN 172MG/DL AND 165MG/DL. CUSTOMER STATES FASTING RANGE SHOULD BE AROUND 130MG/DL. LAST 4 RESULTS IN MEMORY WERE 169MG/DL, 254MG/DL, 144MG/DL AND 140MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587799 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR1869

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR