BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4373126 · Received December 24, 2014

    Report

    Report Number
    1052693-2014-00655
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    November 30, 2014
    Report Date
    December 23, 2014
    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

    (B)(4). RETURNED TEST STRIPS PRODUCED LO READINGS. BLACK CHEMISTRY OBSERVED. MOST LIKELY ROOT CAUSE IS BLACK CHEMISTRY DUE TO IMPROPER STORAGE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". REVIEWED THE RECENT BLOOD RESULTS IN THE METER MEMORY: (B)(6) 2014 - 12:41PM, LO; 11/30/2014- 12:14PM, LO; (B)(6) 2014- 11:58AM, LO; (B)(6) 2014- 1:44AM, LO; (B)(6) 2014- 1:43AM. LO. (B)(6) 2014- 11:58AM 146MG/DL; (B)(6) 2014- 11:27AM 135MG/DL. PERFORMED BLOOD GLUCOSE TEST, LO. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851410 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR1977

    Patients

    Seq Age Sex Outcome Treatment
    1