BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3231785 · Received July 15, 2013

    Report

    Report Number
    1052693-2013-00130
    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 EVALUATION. (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD GLUCOSE RESULTS. PER THE CALLER, RESULTS IN MEMORY 66MG/DL ON (B)(6) 2013 AT 6:07PM, 170MG/DL ON (B)(6) 2013 AT 6:58AM, 74MG/DL ON (B)(6) 2013 AT 5:04AM, AND 160MG/DL ON (B)(6) 2012 AT 11:30PM. CALLER STATES HIS GLUCOSE IS NORMALLY 120MG/DL - 130MG/DL 2 HOURS AFTER A MEAL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327809 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1221

    Patients

    Seq Age Sex Outcome Treatment
    1