BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4110533 · Received September 16, 2014

    Report

    Report Number
    1052693-2014-00316
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    July 21, 2014
    Report Date
    December 24, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVALUATION. (B)(4). MANUFACTURER ACKNOWLEDGES LATENESS OF THE REPORT, PER INTERNAL CORRECTIVE ACTION. THIS REPORT SHOULD HAVE BEEN IDENTIFIED AS REPORTABLE WITHIN 30 DAYS OF THE IDENTIFICATION (08/10/2014).

    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.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. CALLER NORMALLY IS AROUND 180-190MG/DL TWO HOURS AFTER EATING. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE LOWEST RESULT GIVEN (83) AND THE NORMAL RESULT (190) IS LOCATED IN ZONES B/C. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. CALLER NORMALLY IS AROUND 180-190MG/DL TWO HOURS AFTER EATING. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE LOWEST RESULT GIVEN (83) AND THE NORMAL RESULT (190) IS LOCATED IN ZONES B/C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572777 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1707

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR