BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS HBSAG ASSAY

    MDR report key: 1327339 · Received February 25, 2009

    Report

    Report Number
    MW5010106
    Event Type
    Injury
    Date Received
    February 25, 2009
    Date of Event
    August 22, 2008
    Report Date
    February 25, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSITCS
    Product Code
    LOM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS PREGNANT WOMAN TESTED FOR HEPATITIS B SURFACE ANTIGEN -HBSAG- DURING HER FIRST TRIMESTER AND WAS REPORTED TO BE NEGATIVE. SHE HAD TESTED POSITIVE FOR HBSAG FIVE YEARS PREVIOUSLY. THE HOSPITAL RETESTED HER UPON DELIVERY 2009, AND THE RESULT WAS POSITIVE. THE HOSPITAL DID NOT RECEIVE LAB RESULTS FOR SEVERAL DAYS, SO THEY HAD TO GET THE INFANT BACK INTO THE HOSPITAL TO ADMINISTER HEPATITIS B IMMUNE GLOBULIN -HBIG-. AN INFANT WITH A HBSAG POSITIVE MOTHER SHOULD RECEIVE HEPATITIS B VACCINE AND HBIG WITHIN 12 HOURS. BECAUSE THE 2008, LAB RESULT WAS NEGATIVE, THE INFANT DID NOT RECEIVE HBIG UNTIL DAY 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS HBSAG ASSAY NONE LOM ORTHO-CLINICAL DIAGNOSITCS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other