BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3622634 · Received December 12, 2013

    Report

    Report Number
    1052693-2013-00380
    Event Type
    Malfunction
    Date Received
    December 12, 2013
    Date of Event
    November 9, 2013
    Report Date
    December 12, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT LOW BLOOD RESULTS. LOWEST BLOOD TEST IN MEMORY - 83 MG/DL. CALLER STATES HE NORMALLY RANGES FROM 180-195 MG/DL. BASED ON (B)(4), THE BIAS BETWEEN THE LOWEST RESULT IN MEMORY (83) AND THE HIGHEST NORMAL RESULT (195) IS LOCATED IN ZONE C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651340 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1412

    Patients

    Seq Age Sex Outcome Treatment
    1