BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4110551 · Received September 16, 2014

    Report

    Report Number
    1052693-2014-00313
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 10, 2014
    Report Date
    December 21, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVAL. (B)(4). MFR 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 OR USER REUSED TEST STRIP ORUSER'S TEST STRIP HAD POOR FILL.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". ANOTHER TEST PERFORMED ALSO READ "LO". LAST 5 TESTS IN MEMORY: "LO", "LO", "LO", "LO", "LO". CUSTOMER NORMALLY READS BETWEEN 90MG/DL AND 110 MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". ANOTHER TEST PERFORMED ALSO READ "LO". LAST 5 TESTS IN MEMORY: "LO", "LO", "LO", "LO", "LO". CUSTOMER NORMALLY READS BETWEEN 90MG/DL AND 110MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573800 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR