BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE RESULT

    MDR report key: 4251109 · Received November 5, 2014

    Report

    Report Number
    1052693-2014-00488
    Event Type
    Malfunction
    Date Received
    November 5, 2014
    Date of Event
    October 7, 2014
    Report Date
    December 11, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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: STRIP ISSUE. OR USER HAS LOW GLUCOSE VALUE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". LAST 5 TESTS IN MEMORY: "LO", "LO", 173MG/DL, 166MG/DL, 124MG/DL. CUSTOMER NORMALLY READS BETWEEN 43-124MG/DL. BACK TO BACK BLOOD TESTS PERFORMED AT THE TIME OF THE CALL WERE 96 AND 71MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". LAST 5 TESTS IN MEMORY: "LO", "LO", 173MG/DL, 166MG/DL, 124MG/DL. CUSTOMER NORMALLY READS BETWEEN 43-124MG/DL. BACK TO BACK BLOOD TEST PERFORMED AT THE TIME OF THE CALL WERE 96 AND 71 MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710443 TRUE RESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1736

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR