BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON GROUP B STREP ASSAY

    MDR report key: 54574 · Received December 4, 1996

    Report

    Report Number
    2022635-1996-00011
    Event Type
    Malfunction
    Date Received
    December 4, 1996
    Report Date
    December 4, 1996
    Manufacturer
    HYBRITECH INC.
    Product Code
    GTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT WAS RECEIVED REGARDING TWO FEMALE LABOR AND DELIVERY PTS. BOTH WERE TESTED USING THE GROUP B STREP ASSAY LOT NUMBER 690633. RESULTS OF BOTH TESTS WERE NEGATIVE. DUPLICATE SPECIMENS OBTAINED AT THE SAME TIME WERE CULTURED WITH POSITIVE GROUP B STREP HEAVY GROWTH RESULTS. CIRCUMSTANCES REGARDING WHY THE TESTING WAS PERFORMED IS NOT KNOWN. PERSON REPORTING INCIDENT BELIEVES THAT THE BABIES WERE FINE. NO SAMPLES WERE RECEIVED FROM THE CUSTOMER FOR TESTING; THEREFORE, THE COMPLAINTS FOR CULTURE POSITITIVE, ASST NEGATIVE COULD NOT BE EVALUATED. AN OPEN KIT LOT NUMBER 690633 WAS RECEIVED FROM THE CUSTOMER AND TESTED AT CO. TESTING WAS PERFORMED USING THE RETURNED KIT. NEGATIVE CONTROL, POSITIVE CONTROL, AND A SENSITIVITY SAMPLE WERE TESTED AND PRODUCED THE FOLLOWING RESULTS: SAMPLE; EXPECTED RESULT; RESULT: NEGATIVE CONTROL; VISUALLY NEGATIVE; VISUALLY NEGATIVE: POSITIVE CONTROL; VISUALLY POSITIVE; VISUALLY POSITIVE: SENSITIVITY SAMPLE; VISUALLY POSITIVE; VISUALLY POSITIVE. BASED ON THE INFO OBTAINED BY CO TO DATE, NO DEATH OR SERIOUS INJURY HAS OCCURRED BECAUSE OF THIS POSSIBLE MALFUNCTION. CO HAS NO PLANS TO SUBMIT ADD'L INFO PERTAINING TO THIS MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON GROUP B STREP ASSAY GBS TEST GTZ HYBRITECH INC. NA 690633

    Patients

    Seq Age Sex Outcome Treatment
    1 *