BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBAS AMPLICOR CT/NG TEST FOR C. TRACHOMATIS

    MDR report key: 781491 · Received November 15, 2006

    Report

    Report Number
    2243471-2006-00012
    Event Type
    Injury
    Date Received
    November 15, 2006
    Report Date
    October 13, 2006
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC.
    Product Code
    MKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED ROCHE MOLECULAR SYSTEMS WITH SAMPLES FROM THE SPECIMEN IN QUESTION. ROCHE MOLECULAR SYSTEMS, INC. INVESTIGATED THE CUSTOMER'S ALLEGATIONS AND CONFIRMED THAT THE SPECIMENS TESTED NEGATIVE FOR CHLAMYDIA TRACHOMATIS. FURTHER INVESTIGATION DETERMINED THAT THE SPECIMENS CONTAINED A MUTATED STRAIN OF C. TRACHOMATIS. THIS MUTATION RESULTED IN THE DELETION OF APPROXIMATELY 350 BASE PAIRS FROM THE REGION WITHIN THE CRYPTIC PLASMID DNA COVERED BY THE TEST'S PRIMERS / AND OR PROBE. RMS IS CONTINUING OUR INVESTIGATION TO BETTER UNDERSTAND THE PROVALENCE, AND GEOGRAPHIC DISTRIBUTION OF THE MUTATED STRAIN. THE PACKAGE INSERT WILL ALSO BE MODIFIED TO REFLECT THE RARE, BUT POSSIBLE OCCURRENCE OF MUTATIONS THAT COULD IMPACT THE TEST'S PERFORMANCE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PERIOD OF SPECIMENS THAT WERE NEGATIVE FOR CHLAMYDIA TRACHOMATIS WITH THE ROCHE MOLECULAR SYSTEMS COBAS AMPLICOR CT/NG TEST, BUT POSITIVE WITH AN ALTERNATE METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS AMPLICOR CT/NG TEST FOR C. TRACHOMATIS IN VITRO DIAGNOSTIC NUCLEIC ACID TEST MKZ ROCHE MOLECULAR SYSTEMS, INC. * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *