BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEBALANCE

    MDR report key: 4239160 · Received October 31, 2014

    Report

    Report Number
    1052693-2014-00470
    Event Type
    Malfunction
    Date Received
    October 31, 2014
    Date of Event
    October 1, 2014
    Report Date
    December 14, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K090495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT 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. CORRECTION OF 510(K): K090495.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CALLER EXPECTED RANGE IS 80-90 MG/DL. BACK TO BACK BLOOD TEST RESULTS WERE 298 AND 250MG/DL - CONSUMER HAD FOOD/DRINKS AND MEDICATION 3 HOURS AGO. METER MEMORY RESULTS WERE 323MG/DL, 307MG/DL, 140MG/DL, 127MG/DL, AND 201MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT IN MEMORY (323) AND THE NORMAL RESULT (80) IS LOCATE DIN ZONE C/D. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CALLER EXPECTED RANGE IS 80-90 MG/DL. BACK TO BACK BLOOD TEST RESULTS WERE 298 AND 250MG/DL - CONSUMER HAD FOOD/DRINKS AND MEDICATION 3 HOURS AGO. METER MEMORY RESULTS WERE 323MG/DL, 307MG/DL, 140MG/DL, 127MG/DL, AND 201MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT IN MEMORY (323) AND THE NORMAL RESULT (80) IS LOCATED IN ZONE C/D. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698349 TRUEBALANCE BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUBALANCE BR4396

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR