BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4451452 · Received January 22, 2015

    Report

    Report Number
    1052693-2015-00056
    Event Type
    Malfunction
    Date Received
    January 22, 2015
    Date of Event
    December 30, 2014
    Report Date
    January 20, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: TEST STRIPS HAD POOR STORAGE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ERRATIC BLOOD RESULTS. NORMAL BLOOD RANGE IS AROUND 100 MG/DL. RECALLED THE LAST FIVE RESULTS FROM THE METERS MEMORY (THE CUSTOMER STATES THAT THE TIME IS INCORRECT): 95 MG/DL ON (B)(6) 2014 @ 12:23 PM 168 MG/DL ON (B)(6) 2014 @ 12:21 PM 170 MG/DL ON (B)(6) 2014 @ 12:20 PM 164 MG/DL ON (B)(6) 2014 @ 12:20 PM 136 MG/DL ON (B)(6) 2014 @ 12:19 PM NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52881 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1542

    Patients

    Seq Age Sex Outcome Treatment
    1