BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG

    MDR report key: 581107 · Received March 1, 2005

    Report

    Report Number
    9680658-2005-00049
    Event Type
    Malfunction
    Date Received
    March 1, 2005
    Date of Event
    January 7, 2005
    Report Date
    February 7, 2005
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OBTAINED NEGATIVELY BIASED BETA-NCG RESULTS WITH A PATIENT SAMPLE. THE MAGNITUDE AND DIRECTION OF THE BIAS MAY 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 IMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG IN VITRO DIAGNOSTIC DHA ORTHO-CLINICAL DIAGNOSTICS NA 660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA