BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3231739 · Received July 15, 2013

    Report

    Report Number
    1052693-2013-00126
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 11, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. RAN BACK TO BACK BLOOD TEST, 421, 449 MG/DL. MEMORY RESULTS WERE 421 MG/DL, (B)(6) AT 1:31 P (ATE ABOUT AN HR AGO); 304 MG/DL, (B)(6) AT 9:02 A (FASTING); 441 MG/DL, (B)(6) AT 11:43 P; 248 MG/DL, (B)(6) AT 1:11 P; 164 MG/DL, (B)(6) AT 7:49 A (FASTING). CALLER USUALLY TESTS FASTING AND RESULTS RUN ABOUT 130-135 MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327668 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT TN2517

    Patients

    Seq Age Sex Outcome Treatment
    1