BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON IMMUNOCONCENTRATION ASSAY FOR GROUP B STREP

    MDR report key: 44798 · Received October 11, 1996

    Report

    Report Number
    2022635-1996-00002
    Event Type
    Malfunction
    Date Received
    October 11, 1996
    Date of Event
    September 1, 1996
    Report Date
    October 11, 1996
    Manufacturer
    HYBRITECH INCO.
    Product Code
    GTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT WAS TESTED USING THE GROUP B STREP ASSAY LOT NUMBER 690445. THE PERSTON REPORTING THE INCIDENT BELIEVES BUT IS NOT CERTAIN THAT THE SAMPLE WAS OBTAINED JUST PRIOR TO DELIVERY OF THE INFANT. A DUPLICATE SPECIMEN OBTAINED AT THE SAME TIME WAS USED TO STREAK A CULTURE PLATE. THE RESULT OF THE ASSAY WAS NEGATIVE. THE CULTURE RESULT WAS POSITIVE FOR GROUP B STREP. THE CULTURE WAS CONFIRMED WITH A STREP TYPING KIT, MFR UNKNOWN. THE INFANT WAS VERY SICK UPON DELIVERY AND SUBSEQUENTLY DIED. A BLOOD CULTURE FROM THE INFANT WAS PERFORMED AND THE RESULTS WERE NEGATIVE FOR GROUP B STREP. IT WAS LATER DETERMINED THAT THE INFANT DIED FROM ASPHYXIA. NO SAMPLE OR KIT WAS RECEIVED FROM THE CUSTOMER FOR TESTING; THEREFORE, THE COMPLAINT FOR CULTURE POSITIVE. NEGATIVE COULD NOT BE EVALUATED. TESTING WAS PERFORMED AT CO USING AN IN-HOUSE KIT OF THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON IMMUNOCONCENTRATION ASSAY FOR GROUP B STREP GBS GTZ HYBRITECH INCO. NA 690445

    Patients

    Seq Age Sex Outcome Treatment
    1 *