BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4152405 · Received October 3, 2014

    Report

    Report Number
    1052693-2014-00377
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 4, 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
    OK, US
    Reporter Occupation
    OTHER

    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'S TEST STRIP HAD POOR FILL. PRODUCT CODES UPDATED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT ABOUT METER READING LOWER RESULTS THAN DOCTORS OFFICE. CALLER STATES HIS EXPECTED RANGE IS ABOUT 170MG/DL - 180MG/DL WHILE USING THE TRUE RESULT. THE LAST 5 RESULT FROM THE MEMORY ARE: 121MG/DL, 87MG/DL (PHARMACIST RESULT), 146MG/DL (FASTING)141MG/DL (FASTING) AND 139MG/DL (FASTING). BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE NORMAL HIGHEST GLUCOSE RESULT (180) AND THE LOWEST RESULT IN MEMORY (87) IS LOCATED IN ZONE C. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT ABOUT METER READING LOWER RESULTS THAN DOCTORS OFFICE. CALLER STATES HIS EXPECTED RANGE IS ABOUT 170MG/DL - WHILE USING THE TRUERESULT. THE LAST 5 RESULT FROM THE MEMORY ARE: 121MG/DL, 87MG/DL (PHARMACIST RESULT), 146 MG/DL (FASTING) 141 MG/DL (FASTING) AND 139 MG/DL (FASTING). BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE NORMAL HIGHEST GLUCOSE RESULT (180) AND THE LOWEST RESULT IN MEMORY (87) IS LOCATED IN ZONE C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617681 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR1826

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR