BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICON IMMUNOCONCENTRATION ASSAY FOR GROUP B STREP

    MDR report key: 42393 · Received October 11, 1996

    Report

    Report Number
    2022635-1996-00003
    Event Type
    Injury
    Date Received
    October 11, 1996
    Date of Event
    September 8, 1996
    Report Date
    October 11, 1996
    Manufacturer
    HYBRITECH INC.
    Product Code
    GTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFO WAS RECEIVED REGARDING A PT TESTED INTRAPARTUM USING THE DEVICE GBS ASSAY LOT NUMBER 690445. THE PT WAS TESTED DURING LABOR AT 5:30 AM AND DURING DELIVERY AT 11:30 PM ON 9/8/96. DUPLICATE SPECIMENS OBTAINED AT THE SAME TIME WERE USED TO STREAK CULTURE PLATES. THE RESULTS OF THE ASSAYS WERE NEGATIVE. NO ANTIBIOTIC TREATMENT WAS ADMINISTERED TO THE PT BASED ON THE RESULTS. THE CULTURE RESULTS WERE POSITIVE FOR GROUP B STREP. THE CULTURES WERE CONFIRMED WITH A STREP TYPING KIT, MFR UNKNOWN AND BY BACKTYPING USING THE GBS ASSAY. THE INFANT DELIVERED FROM THIS PT WAS SENT TO THE NEONATAL UNIT DUE TO RESPIRATORY DISTRESS. THE BLOOD CULTURE FROM THIS INFANT WAS POSITIVE FOR GBS. THE INFANT IS NOW DOING FINE. 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. REFER TO SECTION H10 FOR TEST RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other