BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS TAQSCREEN MPX TEST

    MDR report key: 2384998 · Received December 21, 2011

    Report

    Report Number
    2243471-2011-00105
    Event Type
    Malfunction
    Date Received
    December 21, 2011
    Date of Event
    December 1, 2011
    Report Date
    January 31, 2012
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZF
    PMA / PMN Number
    BL125255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION THERE WAS NO TREND FOUND IN THE FIELD. QC RELEASE DATA FOR THE KIT BATCHES MET SPECIFICATIONS. NO INTERNAL NON-CONFORMANCES HAVE BEEN GENERATED FOR KIT BATCH 061344. NO PRODUCT OR BATCH NON-CONFORMANCE WAS IDENTIFIED. THE DONOR SAMPLE WAS RETURNED TO ROCHE MOLECULAR DIAGNOSTICS AND SEQUENCED. SEQUENCING REVEALED THE FOLLOWING: (B)(6) SEQUENCES COVERING BOTH GAG AND LTR WERE OBTAINED FROM THE SAMPLE FOR GCS CASE (B)(6). THE SAMPLE WAS DETERMINED TO BE SUBTYPE B BASED ON THE GAG SEQUENCE THAT WAS OBTAINED THE GAG SEQUENCE WAS ALIGNED TO THE GAG PRIMERS AND PROBE OF THE CAP/ CTM HIV-1 TEST, CAP/CTM HIV-1 V2.0 TEST, AND CA-HIM V1.5 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 FROM THIS SAMPLE CONTAINS SEVERAL MISMATCHES TO THE UPSTREAM PRIMER BINDING REGION OF THE TAQSCREEN MPX AND TAQSCREEN MPX V2.0 TEST, AND THE LTR PORTION OF THE CAP/CTM HIV-1 V2.0 TEST, THESE MISMATCHES ARE LIKELY THE CAUSE OF THE (B)(6) RESULT FROM THE MPX V 1.0 TEST. NONE OF THE LTR SEQUENCES OBTAINED IN-HOUSE BY THE GLOBAL SURVEILLANCE PROGRAM OR AVAILABLE FROM THE NCBI THAT COVER THE ASSAY TARGET REGION CONTAIN THE SAME MISMATCHES AS SEEN FOR THIS SAMPLE. SEQUENCING ANALYSIS INDICATED THAT MISMATCHES TO THE (B)(6) SEQUENCE WITHIN THE SAMPLE ARE LIKELY THE CAUSE OF THE (B)(6) RESULT GENERATED BY THE COBAS TAQSCREEN MPX TEST. THE COBAS TAQSCREEN MPX TEST PACKAGE INSERT (M/N 04788397001, REVISION 5.0, 0./2010), PROCEDURAL LIMITATIONS SECTION STATES THAT "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 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. NOTE: PRODUCT CODE MZF WAS SELECTED AS NO ALTERNATIVE / MORE APPLICABLE CODE IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN (B)(6) REPORTED THAT A DONOR SPECIMEN GENERATED A (B)(6) TEST RESULT, FOR (B)(6) WHEN TESTED WITH THE COBAS TAQSCREEN MPX TEST. THE CUSTOMER REPORTED THAT THE DONOR SPECIMEN WAS NON-REACTIVE FOR (B)(6) IN A POOL OF 6 AS WELL AS A RESOLUTION POOL OF ONE WITH THE COBAS TAQSCREEN MPX TEST AND SEROLOGY (B)(6) (ABBOTT PRISM). THE SAMPLE IS ALSO (B)(6) FOR (B)(6) AND (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS TAQSCREEN MPX TEST TEST, HIV DETECTION MZF ROCHE MOLECULAR SYSTEMS 61344

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR