BEUDAMED
    FDA Adverse Event Summary report: N

    COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0

    MDR report key: 2221986 · Received August 24, 2011

    Report

    Report Number
    2243471-2011-00075
    Date Received
    August 24, 2011
    Date of Event
    July 28, 2011
    Report Date
    September 15, 2011
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. OFF-LABEL, UNAPPROVED OR CONTRAINDICATED USE. THE CUSTOMER INDICATED THAT THE CAP/CTM HIV-1 QUAL TEST WAS UNABLE TO DETECT A PLASMID SAMPLE DILUTED IN PBS AND SPEX. NO DATA WAS PROVIDED BY THE CUSTOMER FOR THE CAP/CTM HIV-1 QUAL TEST. WHEN THE PLASMID WAS TESTED WITH THE CAP/CTM HIV-1 TEST, V2.0, THE TITERS WERE LOWER THAN THE TITERS GENERATED WITH THE ABBOTT SYSTEM. THIS IS AN OFF-LABEL SAMPLE TYPE FOR BOTH CAP/CTM HIV-1 TESTS. NO PRODUCT NON-CONFORMANCE WAS IDENTIFIED. SEQUENCING ANALYSIS DETERMINED THAT THE SEQUENCE OF THE PLASMID CONTAINS MISMATCHES TO THE PROBE AND THE DOWNSTREAM PRIMER USED IN THE CAP/CTM HIV-1 QUAL TEST AND BASED ON THE LOCATION AND NUMBER OF MISMATCHES PRESENT, ARE LIKELY TO AFFECT ASSAY PERFORMANCE. FOR THE CAP/CTM HIV TEST, V2.0, NO MISMATCHES WERE DETECTED AND THE TEST WOULD BE EXPECTED TO ACCURATELY QUANTIFY AND DETECT THIS PLASMID. HOWEVER, TESTING PLASMIDS IS CONSIDERED OFF-LABEL AND THE EFFECTS OF SUCH A SAMPLE TYPE ON THE CAP/CTM HIV-1 TEST, V2.0 IS UNKNOWN. THIS TYPE OF PLASMID WAS NEVER TESTED DURING DEVELOPMENT OF THE ASSAY AND ITS AFFECTS ON ASSAY PERFORMANCE ARE UNKNOWN. ADDITIONALLY, THERE IS NO CORRELATION DATA BETWEEN THE CAP/CTM HIV-1 TEST, V2.0 AND THE ABBOTT TEST WITH THIS SAMPLE TYPE. (B)(4).

    Additional Manufacturer Narrative · 1

    FOLLOW UP REPORT 2. ADDITIONAL INFORMATION WAS OBTAINED TO FURTHER EXPLAIN THE INABILITY TO DETECT A PLASMID SAMPLE WITH THE (B)(6). (B)(6) EXTRACTION USING THE COBAS AMPLIPREP SYSTEM IS DEPENDENT ON MAGNETIC BEAD TECHNOLOGY. INFORMATION PROVIDED BY A RELATED ROCHE BUSINESS AREA - (B)(4) - DETERMINED THAT MAGNETIC BEAD TECHNOLOGY IS KNOWN TO BE INEFFICIENT FOR PLASMID EXTRACTION. EXTRACTION USING MAGNETIC BEADS FOR ANY CIRCULARIZED PLASMIDS RESULTED IN VERY POOR EXTRACTION EFFICIENCY, UNLESS THE PLASMID WAS LINEARIZED. THIS COULD EXPLAIN THE CUSTOMER'S INABILITY TO DETECT THE PLASMID SAMPLE WITH THE (B)(6). PLASMID SAMPLES ARE OFF-LABEL SAMPLE TYPES FOR THE (B)(6). (B)(4).

    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. THE ASSOCIATED US PRODUCT IS M/N 05212308190 BP050069. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) WHO IS TESTING DILUTIONS OF AN (B)(6), WHICH IS AN OFF-LABEL SAMPLE TYPE, ALLEGES THAT VIRAL TITERS GENERATED WITH THE CAP/CTM HIV-1 V2 TEST CE-IVD (LOT NUMBER NOT PROVIDED) ARE HALF OF WHAT WAS DETECTED WITH THE ABBOTT TEST. THE CAP/CTM HIV-1 V2 VIRAL TITERS WERE (B)(6). NO TITER RESULTS WERE PROVIDED FOR THE ABBOTT TEST. THERE WERE NO MISMATCHES TO THE LTR REGION PRIMERS/ PROBE OF THE CAP/CTM HIV V2 TEST THAT WOULD BE EXPECTED TO CAUSE AN UNDER-QUANTITATION WITH THE ROCHE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0 TEST, HIV DETECTION MZF ROCHE MOLECULAR SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1