BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4190124 · Received September 18, 2014

    Report

    Report Number
    1052693-2014-00343
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 22, 2014
    Report Date
    December 17, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD POOR TECHNIQUE OR USER'S MISUNDERSTANDING OF ERRATIC RESULTS.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT# (B)(4). PRODUCT NOT YET RETURNED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ERRATIC BLOOD RESULTS. BACK TO BACK BLOOD TESTS PERFORMED AT THE TIME OF THE CALL WERE 180MG/DL AND 166MG/DL - 295MG/DL. ERROR GRID ANALYSIS OF THE BACK TO BACK RESULTS WERE IN ZONE C. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ERRATIC BLOOD RESULTS. BACK TO BACK BLOOD TESTS PERFORMED AT THE TIME OF THE CALL WERE 180MG/DL AND 166M/DL. OTHER BACK TO BACK TESTS PERFORMED WERE 185MG/DL - 295MG/DL. ERROR GRID ANALYSIS OF THE BACK TO BACK RESULTS WERE IN ZONE C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577562 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RP4260

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR