BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3231804 · Received July 15, 2013

    Report

    Report Number
    1052693-2013-00128
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    July 8, 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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD GLUCOSE RESULTS. PER THE CALLER, RESULTS IN MEMORY WERE 85MG/DL ON (B)(6) 2013 AT 11:51AM, 78MG/DL ON (B)(6) 2013 AT 8:15AM, 96MG/DL ON (B)(6) 2013 AT 11:38PM, 83MG/DL ON (B)(6) 2013 AT 3:54PM, 84MG/DL ON (B)(6) 2013 AT 10:02AM, AND 100MG/DL. CALLER STATES GLUCOSE IS NORMALLY 125MG/DL - 135MG/DL 2 HOURS AFTER A MEAL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327632 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1226

    Patients

    Seq Age Sex Outcome Treatment
    1