BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 3802506 · Received February 21, 2014

    Report

    Report Number
    1052693-2014-00137
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 24, 2014
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. PT COMPARED THE TRUE RESULT SYSTEM READING DIRECTLY TO THE DOCTOR'S METER. RESULT READING TO BE INACCURATE. NO PRODUCT NAME OR IDENTIFICATION GIVEN. NO RESULTS GIVEN. NO ADVERSE EVENT REPORTED. REF MW5035306.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111673 UNKNOWN BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1