BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS TAQSCREEN MPX TEST, CE-IVD

    MDR report key: 3120030 · Received May 20, 2013

    Report

    Report Number
    2243471-2013-00010
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    February 23, 2013
    Report Date
    June 7, 2013
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZF
    PMA / PMN Number
    BL125255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME, AS THE INVESTIGATION INTO THIS ISSUE IS ONGOING. THE OUTCOME OF THIS INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A PRIMARY POOL OF 24 TEST RUN USING THE COBAS TAQSCREEN MPX TEST WITH THE COBAS S 201 SYSTEM GENERATED A (B)(6) RESULT. ONE OF THE DONORS IN THE POOL WAS FOUND TO BE SEROLOGY (B)(6). CONFIRMATORY TESTS WERE PERFORMED USING THE ROCHE COBAS® AMPLIPREP® / COBAS® TAQMAN® (CAP/CTM) HIV TEST, VERSION 2.0 AND THE NOVARTIS PROCLEIX ULTRIO ELITE ASSAY AND THE DONOR WAS FOUND TO BE (B)(6) WITH BOTH TESTS. THE BLOOD UNIT WAS NOT RELEASED FOR DONATION. AS (B)(6) VIRAL LOADS OF 8545 AND 9920 COPIES/ML WERE OBTAINED FOR THE SAMPLE WHEN TESTED WITH THE ROCHE COBAS® AMPLIPREP®/ COBAS® TAQMAN® HIV-1 V2.0 TEST AND A NON-ROCHE QUANTITATIVE TEST (ABBOTT REALTIME (B)(6) TEST) RESPECTIVELY, GENETIC SEQUENCING WAS PERFORMED TO DETERMINE IF THERE WERE ANY SAMPLE MISMATCHES THAT MAY EXPLAIN THE RESULT DISCREPANCIES REPORTED IN THIS CASE. THE FOLLOWING CONCLUSIONS WERE MADE FROM THE GENETIC SEQUENCING RESULTS: THE (B)(6) SEQUENCES COVERING THE GAG AND LTR TARGET REGIONS WERE OBTAINED FROM THE DONOR SAMPLE. THE SUBTYPE WAS DETERMINED TO BE (B)(6), GROUP M SUBTYPE B. THE GAG SEQUENCE WAS ALIGNED TO THE GAG PRIMERS AND PROBE OF THE CAP/CTM HIV-1 (V1.0) TEST, AND CAP/CTM HIV-1 V2.0 TEST. THE MISMATCHES OBSERVED IN THE PRIMER AND PROBE BINDING REGION FOR THIS SAMPLE ARE NOT LIKELY TO AFFECT ASSAY PERFORMANCE BASED ON THE LOCATION AND NUMBER OF MISMATCHES. THE LTR SEQUENCE THAT WAS OBTAINED FOR THE SAMPLE CONTAINS SEVERAL MISMATCHES TO THE UPSTREAM PRIMER BINDING REGION OF THE COBAS® TAQSCREEN MPX AND COBAS® TAQSCREEN MPX V2.0 TEST, AND THE LTR PORTION OF THE CAP/CTM HIV-1 V2.0 TEST. THESE MISMATCHES WOULD AFFECT THE DETECTION OF THE LTR TARGET REGION BY PREVENTING THE UPSTREAM PRIMER FROM BINDING AND ARE THEREFORE LIKELY THE CAUSE OF THE (B)(6) RESULT FROM THE COBAS® TAQSCREEN MPX TEST, AS THEY ONLY CONTAIN THE ASSAY PRIMERS AND PROBES FOR DETECTING THE LTR REGION OF (B)(6). THE GENETIC SEQUENCING DATA INDICATES THAT DETECTION OF (B)(6) IN THE COMPLAINT SAMPLE COULD ONLY BE ACHIEVED WITH A TEST THAT TARGETS THE GAG REGION OR GAG AND LTR REGIONS (BOTH) AND NOT ONLY THE LTR DUE TO SEQUENCE MISMATCHES PRESENT IN THIS REGION FOR THE SAMPLE. GIVEN THAT THE COBAS® TAQSCREEN MPX TEST TARGETS THE LTR REGION, NO DETECTION OF (B)(6) IN THE COMPLAINT SAMPLE WOULD BE POSSIBLE AT THE CUSTOMER SITE, OR WITH THIS PRODUCT. SUCCESSFUL DETECTION OF (B)(6) IN THE COMPLAINT SAMPLE, WOULD BE CONTINGENT UPON USING A TEST THAT DOES NOT ONLY TARGET THE LTR REGION. AS STATED IN THE PROCEDURAL LIMITATIONS SECTION OF THE COBAS® TAQSCREEN MPX TEST PACKAGE INSERT, "THOUGH RARE, MUTATIONS WITHIN THE HIGHLY CONSERVED REGIONS OF THE VIRAL GENOMES COVERED BY THE COBAS® TAQSCREEN MPX TEST PRIMERS AND/OR PROBES MAY RESULT IN FAILURE TO DETECT A VIRUS." (B)(4).

    Additional Manufacturer Narrative · 1

    A PRIMARY POOL OF 24 TEST RUN USING THE COBAS TAQSCREEN MPX TEST WITH THE COBAS S 201 SYSTEM GENERATED A NON-REACTIVE RESULT. ONE OF THE DONORS IN THE POOL WAS FOUND TO BE SEROLOGY (B)(6) FOR (B)(6). CONFIRMATORY TESTS WERE PERFORMED USING THE ROCHE COBAS® AMPLIPREP® / COBAS® TAQMAN® (CAP/CTM) HIV TEST, VERSION 2.0 AND THE NOVARTIS PROCLEIX ULTRIO ELITE ASSAY AND THE DONOR WAS FOUND TO BE (B)(6) WITH BOTH TESTS. THE BLOOD UNIT WAS NOT RELEASED FOR DONATION. AS (B)(6) VIRAL LOADS OF 8545 AND 9920 COPIES/ML WERE OBTAINED FOR THE SAMPLE WHEN TESTED WITH THE ROCHE COBAS® AMPLIPREP®/ COBAS® TAQMAN® HIV-1 V2.0 TEST AND A NON-ROCHE QUANTITATIVE TEST (ABBOTT REALTIME (B)(6) TEST) RESPECTIVELY, GENETIC SEQUENCING WAS PERFORMED TO DETERMINE IF THERE WERE ANY SAMPLE MISMATCHES THAT MAY EXPLAIN THE RESULT DISCREPANCIES REPORTED IN THIS CASE. THE FOLLOWING CONCLUSIONS WERE MADE FROM THE GENETIC SEQUENCING RESULTS: THE (B)(6) SEQUENCES COVERING THE GAG AND LTR TARGET REGIONS WERE OBTAINED FROM THE DONOR SAMPLE. THE SUBTYPE WAS DETERMINED TO BE (B)(6), GROUP M SUBTYPE B. THE GAG SEQUENCE WAS ALIGNED TO THE GAG PRIMERS AND PROBE OF THE CAP/CTM HIV-1 (V1.0) TEST, AND CAP/CTM HIV-1 V2.0 TEST. THE MISMATCHES OBSERVED IN THE PRIMER AND PROBE BINDING REGION FOR THIS SAMPLE ARE NOT LIKELY TO AFFECT ASSAY PERFORMANCE BASED ON THE LOCATION AND NUMBER OF MISMATCHES. THE LTR SEQUENCE THAT WAS OBTAINED FOR THE SAMPLE CONTAINS SEVERAL MISMATCHES TO THE UPSTREAM PRIMER BINDING REGION OF THE COBAS® TAQSCREEN MPX AND COBAS® TAQSCREEN MPX V2.0 TEST, AND THE LTR PORTION OF THE CAP/CTM HIV-1 V2.0 TEST. THESE MISMATCHES WOULD AFFECT THE DETECTION OF THE LTR TARGET REGION BY PREVENTING THE UPSTREAM PRIMER FROM BINDING AND ARE THEREFORE LIKELY THE CAUSE OF THE NON-REACTIVE RESULT FROM THE COBAS® TAQSCREEN MPX TEST, AS THEY ONLY CONTAIN THE ASSAY PRIMERS AND PROBES FOR DETECTING THE LTR REGION OF (B)(6). THE GENETIC SEQUENCING DATA INDICATES THAT DETECTION OF (B)(6) IN THE COMPLAINT SAMPLE COULD ONLY BE ACHIEVED WITH A TEST THAT TARGETS THE GAG REGION OR GAG AND LTR REGIONS (BOTH) AND NOT ONLY THE LTR DUE TO SEQUENCE MISMATCHES PRESENT IN THIS REGION FOR THE SAMPLE. GIVEN THAT THE COBAS® TAQSCREEN MPX TEST TARGETS THE LTR REGION, NO DETECTION OF (B)(6) IN THE COMPLAINT SAMPLE WOULD BE POSSIBLE AT THE CUSTOMER SITE, OR WITH THIS PRODUCT. AS STATED IN THE PROCEDURAL LIMITATIONS SECTION OF THE COBAS® TAQSCREEN MPX TEST PACKAGE INSERT, "THOUGH RARE, MUTATIONS WITHIN THE HIGHLY CONSERVED REGIONS OF THE VIRAL GENOMES COVERED BY THE COBAS® TAQSCREEN MPX TEST PRIMERS AND/OR PROBES MAY RESULT IN FAILURE TO DETECT A VIRUS." (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN (B)(6) FILED A COMPLAINT ALLEGING THAT A (B)(6) RESULT WAS GENERATED WITH THE COBAS TAQSCREEN MPX TEST. A PRIMARY POOL OF 24 TEST RUN USING THE MPX TEST WITH THE COBAS S 201 SYSTEM GENERATED A (B)(6) RESULT. ONE OF THE DONORS IN THE POOL WAS FOUND TO BE SEROLOGY (B)(6). CONFIRMATORY TESTS WERE PERFORMED USING THE ROCHE COBAS AMPLIPREP / COBAS TAQMAN (CAP/CTM) HIV TEST, VERSION 2.0 AND THE NOVARTIS PROCLEIX ULTRIO ELITE ASSAY AND THE DONOR WAS FOUND TO BE (B)(6) WITH BOTH TESTS. THE BLOOD UNIT WAS NOT USED FOR DONATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222094 COBAS TAQSCREEN MPX TEST, CE-IVD TEST, HIV DETECTION MZF ROCHE MOLECULAR SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1