BEUDAMED
    FDA Adverse Event Summary report: N

    COBAS TAQSCREEN MPX TEST

    MDR report key: 2016439 · Received March 11, 2011

    Report

    Report Number
    2243471-2011-00015
    Date Received
    March 11, 2011
    Date of Event
    March 24, 2010
    Report Date
    February 9, 2011
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZP
    PMA / PMN Number
    BL 125255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. HOWEVER, AS SPECIFIED WITHIN THE PRODUCT LABELING, OUT OF (B)(6) SPECIMENS TEST IN AN HCV (B)(6) POPULATION, (B)(6) SPECIMENS WERE (B)(6) WITH THE COBAS TAQSCREEN MPX TEST. THESE DATA DEMONSTRATE THAT UP TO (B)(6) OF HCV (B)(6) SPECIMENS CAN BE EXPECTED TO BE (B)(6) FOR HCV WITH THE COBAS TAQSCREEN MPX TEST. THE OUTCOME OF THIS INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. NOTE: PRODUCT CODE MZP WAS SELECTED AS THE CUSTOMER ALLEGATION INDICATES THAT THE DONATION WAS FALSE (B)(6) FOR HCV. THERE IS NO PRODUCT CODE FOR AN ASSAY THAT SIMULTANEOUSLY DETECTS FOR HBV/HCV/HIV. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A SUMMARY OF THE TESTING OF THE 23 SAMPLES THAT GENERATED THE DISCREPANT RESULTS BETWEEN THE COBAS TAQSCREEN MPX TEST AND SEROLOGY IS AS FOLLOWS: REPEAT SEROLOGY TESTING PERFORMED ON ALL THE SAMPLES THAT GENERATED A POSITIVE HCV SEROLOGY RESULT REPRODUCED THE INITIAL POSITIVE RESULT. SOME DONORS DONATED A SECOND TIME AND THE SECOND DONATION REPRODUCED THE POSITIVE HCV SEROLOGY RESULTS SEEN DURING THE INITIAL AND REPEAT TESTING OF THE FIRST DONATION. THE CUSTOMER DID NOT REPEAT THE TESTING WITH THE COBAS TAQSCREEN MPX TEST FOR ANY OF THE 23 SAMPLES. NONE OF THE 23 SAMPLES WERE AVAILABLE FOR SEQUENCING OR FURTHER INVESTIGATIVE TESTING. NO PRODUCT NON-CONFORMANCE WAS IDENTIFIED AS: THE PROCEDURAL LIMITATIONS SECTION OF THE PACKAGE INSERT STATES: "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." THUS, IF SOME OF THE DONOR SAMPLES CONTAINED MISMATCHES TO THE PRIMERS AND/OR PROBES IN THE COBAS TAQSCREEN MPX TEST, THEY WOULD GENERATE NEGATIVE RESULTS. AS THE SAMPLES WERE NOT AVAILABLE FOR SEQUENCING AND THE SAMPLES WERE NOT TESTED WITH ANOTHER PCR TEST, IT CANNOT BE CONFIRMED THAT SOME OF THE SAMPLES CONTAINED MISMATCHES. THE ANALYTICAL SENSITIVITY SECTION OF THE PACKAGE INSERT INDICATES THAT THE LIMIT OF DETECTION (LOD) FOR THE TEST FOR HCV IS 11 IU/ML FOR SINGLE UNIT TESTING. FOR PRIMARY POOLS OF 6, THE LOD IS CALCULATED TO BE 66 IU/ML. SOME OF THE SAMPLES THAT DISPLAYED DISCREPANT MAY HAVE AN (B)(4) LOAD BELOW THE LOD AND THUS WOULD GENERATE A NEGATIVE RESULT FOR THE COBAS TAQSCREEN MPX TEST. AS SPECIFIED IN PRODUCT LABELING, OUT OF 961 SPECIMENS TESTED IN AN (B)(4) SPECIMENS WERE REACTIVE WITH THE COBAS TAQSCREEN MPX TEST. THESE DATA DEMONSTRATE THAT UP TO (B)(4) (THIS NUMBER WAS ORIGINALLY PORTRAYED AS (B)(4), HOWEVER AFTER REVIEW IT WAS DETERMINED THAT THE CORRECT VALUE SHOULD BE (B)(4)) OF (B)(4) SPECIMENS CAN BE EXPECTED TO BE NON-REACTIVE FOR (B)(4) WITH THE COBAS TAQSCREEN MPX TEST. ACCORDING TO THE PUBLICATION, PATHOPHYSIOLOGY OF HEPATITIS C VIRUS INFECTION AND RELATED LIVER DISEASE (TRENDS MICROBIOL. 2004 12:96-102), A DONOR WITH AN ACUTE HCV INFECTION WOULD NOT LIKELY HAVE DETECTABLE HCV RNA ABOUT 6 MONTHS AFTER INFECTION, WHILE THE ANTIBODIES FOR HCV ARE STILL IN HIGH NUMBERS AND DETECTABLE. THUS, SOME OF THE SAMPLES INCLUDED IN THIS CASE COULD HAVE BEEN FROM DONORS WITH ACUTE HCV INFECTION AT THIS LATER STAGE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN (B)(6) REPORTED THAT A (B)(6) RESULT WAS GENERATED WITH THE COBAS TAQSCREEN MPX TEST; HOWEVER, THE DONATION WAS (B)(6) FOR HCV WITH THE DIASORIN A-HCV VERSION 4.0 TEST. THE CUSTOMER SITE REPORTED THAT IN 2010 THEY HAD A TOTAL OF 23 PATIENT DONATIONS THAT WERE (B)(6) WITH THE COBAS TAQSCREEN MPX TEST AND (B)(6) FOR HCV. IN TOTAL, 7 COBAS TAQSCREEN MPX TEST KIT LOTS WERE UTILIZED FOR THESE 23 DONATIONS. THEREFORE, ONE MEDICAL DEVICE REPORT PER DONATION IS BEING FILED (MDR NUMBERS 2243471-2011-00012 THROUGH -00034).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS TAQSCREEN MPX TEST ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA AND HBV DNA MZP ROCHE MOLECULAR SYSTEMS M09942

    Patients

    Seq Age Sex Outcome Treatment
    1