BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4110548 · Received September 16, 2014

    Report

    Report Number
    1052693-2014-00314
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 9, 2014
    Report Date
    January 8, 2016
    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

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. RETURNED TEST STRIPS EVALUATED WITH A DEFECT FOUND. THE ROOT CAUSE OF THIS MALFUNCTION WAS IDENTIFIED BLACK CHEMISTRY WAS OBSERVED ON THE STRIP DUE TO IMPROPER STORAGE CONDITIONS.

    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 (08/09/2014.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING "LO". CUSTOMER DECLINED TO PERFORM A BLOOD TEST DURING TIME OF CALL AND DECLINED TO REVIEW THE METER MEMORY. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". CUSTOMER DECLINED TO PERFORM A BLOOD TEST DURING TIME OF CALL AND DECLINED TO REVIEW THE METER MEMORY. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573799 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PN1004

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR