BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRUERESULT

    MDR report key: 3032659 · Received March 15, 2013

    Report

    Report Number
    1052693-2013-00019
    Event Type
    Other
    Date Received
    March 15, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 15, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 RESULTS. CALLED EMT FOR ASSISTANCE. NO OUTCOME PROVIDED. CONTROL SOLUTION PERFORMED AND RESULT WAS IN RANGE. AT THE TIME OF THE CALL, THE DAUGHTER DID NOT WANT TO PERFORM A BLOOD TEST ON THE MOTHER BECAUSE THE MOTHER HAD JUST FINISHED A MEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110411 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PN1028

    Patients

    Seq Age Sex Outcome Treatment
    1