BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4373156 · Received December 24, 2014

    Report

    Report Number
    1052693-2014-00654
    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
    LFR
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 DUE TO IMPROPER STORAGE. NO FURTHER INVESTIGATION REQUIRED. DEFECT FOUND.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". PERFORMED BLOOD TEST RESULTING IN LO. PERFORMED A 2ND BLOOD TEST- LO. REVIEWED THE METER MEMORY: (B)(6) 2014, 9:53AM, 94MG/DL; (B)(6) 2014, 11:36AM, 105MG/DL; (B)(6) 2014, 9:54AM, 96MG/DL; (B)(6) 2014, 11:15AM, 118MG/DL; (B)(6) 2014, 8:41PM, 99MG/DL. CUSTOMER DATE AND TIME IS INCORRECT. CUSTOMER'S NORMAL RANGE FOR HIS BLOOD TEST IS 130MG/DL-140MG/DL 1 OR 2 HOURS AFTER A MEAL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850698 TRUERESULT BLOOD GLUCOSE SYSTEM LFR NIPRO DIAGNOSTICS, INC. TRUERESULT PP1580

    Patients

    Seq Age Sex Outcome Treatment
    1