BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4122525 · Received September 22, 2014

    Report

    Report Number
    1052693-2014-00357
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    August 28, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND.

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING "LO". CUSTOMER'S NORMAL RANGE SHOULD BE 110MG/DL FASTING AND 140MG/DL 2 HOURS AFTER A MEAL. BACK TO BACK BLOOD TESTS PERFORMED AT THE TIME OF THE ALL RESULTED IN "LO" AND 192 MG/DL. ONLY RESULT IN MEMORY WAS 105MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT BLOOD RESULT READING "LO." CUSTOMER'S NORMAL RANGE SHOULD BE 110MG/DL FASTING AND 140MG/DL 2 HOURS AFTER A MEAL. BACK TO BACK BLOOD TESTS PERFORMED AT THE TIME OF THE CALL RESULTED IN "LO" AND 192MG/DL. ONLY RESULT IN MEMORY WAS 105MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587501 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RP4260

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR