BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD DIRECTIGEN MENINGITIS COMBO TEST KIT

    MDR report key: 1100908 · Received August 7, 2008

    Report

    Report Number
    1119779-2008-00010
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    May 27, 2008
    Report Date
    August 7, 2008
    Manufacturer
    BD DIAGNOSTICS
    Product Code
    GTJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO RETURNS OF THE KIT OR THE ORGANISM WERE AVAILABLE FROM THE CUSTOMER. TROUBLESHOOTING WITH CUSTOMER DID REVEAL THAT THE CUSTOMER CENTRIFUGED THE SAMPLE AT 1.400RPM RATHER THAN 1400G. CENTRIFUGATION AT 1400G FOR 10 MINUTES IS DONE TO REMOVE CELLULAR DEBRIS AND THE SUPERNATANT IS THEN TESTED. RETENTION KIT WAS EXAMINED. THREE STAINS OF ENTEROBACTER CLOACAE (ATCC STRAINS 13047, 35030 AND 23355) WERE TESTED USING ISOLATED COLONIES PER THE PACKAGE INSERT INSTRUCTIONS. ALL RESULTS WERE SATISFACTORY. NO INTERACTIONS WERE OBSERVED WITH NEISSERIA MENINGITIDIS TYPE A. THE BATCH HISTORY RECORD WAS REVIEWED WITH ACCEPTABLE RESULTS. BD WILL CONTINUE TO MONITOR THIS PRODUCT FOR TRENDS.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY, WAS UTILIZING THE BD DIRECTIGEN MENINGITIS COMBO TEST KIT (DMCK). THE LAB TESTED TWO SPINAL FLUID SAMPLES FROM A NEWBORN WITH THE DMCK KIT AND GOT A POSITIVE RESULT FOR NEISSERIA MENINGITIDIS TYPE A. THE CULTURE GREW OUT ENTEROBACTER CLOACAE. THE CUSTOMER ALSO DIRECTLY TESTED THE ORGANISM WITH THE KIT AND A POSITIVE RESULT WITH NEISSERIA MENINGITIDIS TYPE A WAS OBTAINED. THE NEWBORN WAS ALREADY BEING TREATED FOR A POSITIVE BLOOD CULTURE INFECTION WHEN THE CSF WAS FIRST COLLECTED DUE TO THE BEGINNING OF NEUROLOGICAL SYMPTOMS. NO CHANGE IN TREATMENT OCCURRED DUE TO DMCK RESPONSE. THE DIRECTIGEN MENINGITIS COMBO TEST IS A PRESUMPTIVE LATEX AGGLUTINATION TEST FOR THE DIRECT QUALITATIVE DETECTION OF ANTIGENS TO H. INFLUENZAE TYPE B, S. PNEUMONIAE, N. MENINGITIDIS GROUPS A, B, C, Y OR W135 AND ESCHERICHIA COLI K1 IN CEREBROSPINAL FLUID (CSF), SERUM OR URINE. THE TEST CAN ALSO BE USED FOR THE DIRECT QUALITATIVE DETECTION OF ANTIGENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD DIRECTIGEN MENINGITIS COMBO TEST KIT GTJ BD DIAGNOSTICS 8052038

    Patients

    Seq Age Sex Outcome Treatment
    1 Other