BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4223671 · Received August 5, 2014

    Report

    Report Number
    1052693-2014-00233
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    June 21, 2014
    Report Date
    December 24, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE. PRODUCT CODES UPDATED. CORRECTION OF DATE OF EVENT: (B)(6) 2014.

    Description of Event or Problem · 1

    CONSUMER COMPLAINTS OF ABOUT HIGH BLOOD RESULTS. CUSTOMER NORMAL RESULTS ARE 120-140MG/DL FASTING AND TWO HOURS AFTER MEALS. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT IN MEMORY (414) AND THE LOWEST NORMAL RESULT (120) IS LOCATED IN ZONE C. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. CUSTOMER NORMAL RESULTS ARE 120-140MG/DL FASTING AND TWO HOURS AFTER MEALS. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT IN MEMORY (414) AND THE LOWEST NORMAL RESULT (120) IS LOCATED IN ZONE C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456345 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1156

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR