BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE RESULT

    MDR report key: 4122532 · Received September 22, 2014

    Report

    Report Number
    1052693-2014-00350
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    August 24, 2014
    Report Date
    January 7, 2016
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION USER HAD AN INACCURATE REFERENCE .

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "HI". CUSTOMER NORMALLY READS 135-165MG/DL. PERFORMED BACK TO BACK BLOOD TESTS AT THE TIME OF THE CALL - 599MG/DL AND 555MG/DL (HAD BEEN MORE THAN 2 1/2 HOURS SINCE HER LAST MEAL). LAST 5 BLOOD RESULTS IN MEMORY: HI, HI, 535MG/DL, 469MG/DL, 420MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "HI". CUSTOMER NORMALLY READS 135-165MG/DL. PERFORMED BACK TO BACK BLOOD TESTS AT THE TIME OF THE CALL - 599MG/DL AND 555 MG/DL (HAD BEEN MORE THAN 2 1/2 HOURS SINCE HER LAST MEAL). LAST 5 BLOOD RESULTS IN MEMORY: HI, HI, 535 MG/DL, 469MG/DL, 420 MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587794 TRUE RESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1736

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR