BEUDAMED
    FDA Adverse Event Summary report: N

    LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT

    MDR report key: 2526636 · Received April 11, 2012

    Report

    Report Number
    2243471-2012-00017
    Date Received
    April 11, 2012
    Date of Event
    January 27, 2012
    Report Date
    May 11, 2012
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    JJF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION THERE WAS NO INTERNAL NONCONFORMANCES GENERATED FOR KIT BATCH P09467. QC RELEASE DATA FOR THE KIT BATCH MET SPECIFICATIONS. NO PRODUCT OR BATCH NON-CONFORMANCE WAS IDENTIFIED. NO TREND WAS OBSERVED ON THE COMPLAINT ISSUE. NO TESTING OF THE RETENTION KIT WAS PERFORMED AS THE SEQUENCING OF THE RETURNED PATIENT SAMPLE INDICATED: THE CUSTOMER-RETURNED ISOLATE WAS DETERMINED TO BE (B)(6). THE RE SEQUENCE THAT WAS OBTAINED LACKS AN (B)(6) ADVANCED TEST UPSTREAM PRIMER BINDING SITE, AND THEREFORE CANNOT BE DETECTED. AS INDICATED IN THE LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT PACKAGE INSERT IN THE PROCEDURAL LIMITATIONS SECTION: INTERPRETATION OF RESULTS: A (B)(6) LIGHTCYCLER MRSA ADVANCED TEST DOES NOT PRECLUDE (B)(6) NASAL COLONIZATION. QUALITY CONTROL: TO DATE, SEVEN (B)(6) HAVE BEEN DISTINGUISHED, AND SEVERAL VARIANTS OF THESE (B)(6) TYPES HAVE BEEN DESCRIBED. THE LIGHTCYCLER MRSA ADVANCED TEST IS BASED ON A PROPRIETARY DETECTION SYSTEM WHICH IS ABLE TO DETECT (B)(6) STRAINS WITH DIFFERENT MOLECULAR SEQUENCES IN THE VICINITY SURROUNDING THE (B)(6) CASSETTE WITH THE ORFX GENE. THE RE TYPES THAT HAVE BEEN SHOWN TO BE DETECTED BY THE LIGHTCYCLER MRSA TEST INCLUDE (B)(6). IN ADDITION, SEQUENCE ANALYSIS OF TYPE (B)(6) HAS SHOWN 100% HOMOLOGY TO THE PRIMERS AND PROBES USED IN THE LIGHTCYCLER 2.0 MRSA ADVANCED TEST. PROCEDURAL LIMITATIONS: THOUGH RARE, MUTATIONS OR POLYMORPHISMS WITHIN THE REGION OF THE BACTERIAL GENOME COVERED BY THE TEST'S PRIMERS AND/OR PROBE MAY IMPAIR DETECTION. (B)(4).

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AT THIS TIME AS THE INVESTIGATION INTO THIS ISSUE IS ONGOING. THE CONCLUSION OF THE INVESTIGATION WILL BE SUBMITTED THROUGH A FOLLOW-UP REPORT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) FILED A COMPLAINT ALLEGING THAT A (B)(6) RESULT WAS GENERATED WHEN USING THE LIGHTCYCLER (B)(9) ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 CE-IVD ((B)(4)). THE CUSTOMER SENT THE SAMPLE TO AN ASSOCIATED REFERENCE LAB AND THE SAMPLE GENERATED THE FOLLOWING RESULTS: (B)(6). THE ISOLATE IS BEING RETURNED FOR INVESTIGATIVE TESTING / SEQUENCING ANALYSIS. IT WAS STATED IN THE CASE THAT THERE WAS NO CHANGE MADE TO PATIENT TREATMENT AND NO PATIENT HARM DUE TO THE GENERATION OF THE (B)(6) RESULT IN QUESTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM FOR MRSA JJF ROCHE MOLECULAR SYSTEMS P09467

    Patients

    Seq Age Sex Outcome Treatment
    1