BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-NCG REAGENT PACK

    MDR report key: 647655 · Received September 26, 2005

    Report

    Report Number
    9680658-2005-00231
    Event Type
    Malfunction
    Date Received
    September 26, 2005
    Date of Event
    August 29, 2005
    Report Date
    August 29, 2005
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEGATIVELY BIASED TOTAL B-NCG RESULT ON ONE PATIENT'S SAMPLE. THE RESULT WAS NOT REPORTED. A BIAS OF THE MAGNITUDE OBSERVED MIGHT LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-NCG REAGENT PACK IN VITRO DIAGNOSTIC DHA ORTHO-CLINICAL DIAGNOSTICS NA 680

    Patients

    Seq Age Sex Outcome Treatment
    1 NA