BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4384209 · Received December 30, 2014

    Report

    Report Number
    1052693-2014-00661
    Event Type
    Malfunction
    Date Received
    December 30, 2014
    Date of Event
    December 4, 2014
    Report Date
    December 8, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 HIGH GLUCOSE VALUE. CORRECTION OF DATE OF EVENT:(B)(6) 2015.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "HI". REVIEWED THE ONLY RESULTS AVAILABLE IN THE METER MEMORY: "HI" (B)(6) 2014 - 7:40PM, "HI" (B)(6) 2014 - 7:32PM, "HI" (B)(6) 2014 - 7:26PM. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "HI". REVIEWED THE ONLY RESULTS AVAILABLE IN THE METER MEMORY: (B)(6). NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858871 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1557

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR