BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4122529 · Received September 22, 2014

    Report

    Report Number
    1052693-2014-00354
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    August 26, 2014
    Report Date
    December 17, 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 EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAS LOW GLUCOSE VALUE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO." LAST 5 TESTS IN MEMORY ALL WERE "LO." PERFORMED BACK TO BACK BLOOD TESTS AT THE TIME OF THE CALL - 309MG/DL AND 275MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". LAST 5 TESTS IN MEMORY ALL WERE "LO'. PERFORMED BACK TO BACK BLOOD TEST AT THE TIME OF THE CALL - 309MG/DL AND 275 MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587654 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1542

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR