BEUDAMED
    FDA Adverse Event Summary report: N

    COBAS TAQSCREEN MPX TEST CE-IVD

    MDR report key: 3745750 · Received April 11, 2014

    Report

    Report Number
    2243471-2014-00011
    Date Received
    April 11, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 19, 2014
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZP
    PMA / PMN Number
    1636 125255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF REPORT 6/19/2014. DATE RECEIVED BY MANUFACTURER 6/19/2014. FOLLOW UP REPORT 1. ADDITIONAL INFORMATION / DEVICE EVALUATION. DEVICE EVALUATED BY MANUFACTURER: YES. (B)(4). THE CUSTOMER GENERATED THREE DISCREPANT RESULTS WITH THE COBAS TAQSCREEN MPX TEST RELATIVE TO SEROLOGY TESTING. THREE DONOR SAMPLES TESTED IN PRIMARY POOLS OF 6 (PP6) WITH THE MPX TEST GENERATED MPX (B)(6) RESULTS. HOWEVER, THE THREE DONORS WERE (B)(6). FURTHER CONFIRMATORY TESTING FOR (B)(6) USING A RECOMBINANT IMMUNOBLOT ASSAY (RIBA) CONFIRMED THE THREE DONOR SAMPLES WERE (B)(6). DUE TO THE (B)(6) RESULTS OBTAINED, THE THREE DONOR SAMPLES WERE NOT RELEASED FOR DONATIONS. THE DATAFILES CONTAINING THE COMPLAINT DATA COULD NOT BE PROVIDED FOR REVIEW, AS THE RESULTS HAD BEEN PURGED FROM THE CUSTOMER'S COBAS S 201 SYSTEM. THIS MDR ADDRESSES SAMPLE #2 THERE WAS INSUFFICIENT SAMPLE VOLUME LEFT TO PERFORM RESOLUTION TESTING WITH THE COBAS TAQSCREEN MPX TEST TO INVESTIGATE. THEREFORE, THE CUSTOMER RETURNED SAMPLE WAS TESTED WITH THE COBAS TAQMAN (B)(6) TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM AND A 'TARGET NOT DETECTED' (TND) RESULT WAS OBTAINED FOR THE SAMPLE. THE LOD OF THE COBAS TAQMAN (B)(6) TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM IS 20 IU/ML WHILE THE LOD OF THE (B)(6) TARGET USED BY THE CUSTOMER (MPX TEST USING PP6) IS 66 IU/ML. THIS TND RESULT DOES NOT NECESSARILY MEAN THE (B)(6) TARGET IS NOT PRESENT IN THE SAMPLE BUT THE ABSENCE OF DETECTION COULD ALSO BE DUE TO THE (B)(6) TITER IN THE SAMPLE BEING BELOW THE LOD OF THE (B)(6) TEST USED. AS 'TARGET NOT DETECTED' RESULTS WERE OBTAINED FOR THE SAMPLE DURING TESTING WITH THE COBAS TAQMAN (B)(6) TEST, GENETIC SEQUENCING WAS PERFORMED WITH THE REMAINING VOLUME TO DETERMINE IF THERE WERE ANY SEQUENCE MISMATCHES IN THE SAMPLE THAT MAY EXPLAIN THE RESULT DISCREPANCIES REPORTED IN THIS CASE. THE FOLLOWING CONCLUSIONS WERE MADE FROM THE GENETIC SEQUENCING RESULTS: DESPITE SEVERAL ATTEMPTS TO OBTAIN (B)(6) SEQUENCES FROM THE CUSTOMER RETURNED SAMPLE, NO VIRAL SEQUENCES WERE OBTAINED. THE LACK OF (B)(6) SEQUENCE DOES NOT NECESSARILY MEAN THAT NO (B)(6) WAS PRESENT IN THE SAMPLE. THE LACK OF SEQUENCE INFORMATION COULD BE DUE TO SEQUENCE HETEROGENEITY UNDER THE PRIMERS USED FOR SEQUENCING OR DUE TO LOW VIRAL TITERS. RETAIN TESTING OF THE COMPLAINT LOT 122992 GENERATED VALID RESULTS FOR ALL CONTROLS AND QC STANDARDS TESTED WITH NO DISCREPANT RESULTS OBTAINED. THE RETAIN TESTING RESULTS CONFIRM APPROPRIATE TEST PERFORMANCE AND FUNCTIONALITY OF THE COMPLAINT KIT LOT. ACCORDING TO THE MPX PACKAGE INSERT (M/N 05888212001, DOC REV. 9.0), THE DISCREPANT RESULTS OBTAINED IN THIS GLOBAL CASE MAY BE EXPLAINED BY: MUTATIONS PRESENT IN THE MPX DETECTION TARGET REGION WHICH CAN RESULT IN FAILURE TO DETECT THE HCV TARGET AND/OR LOW HCV VIRAL TITERS PRESENT IN THE SAMPLE TESTED. THE MPX TEST IS MOST SENSITIVE DURING INDIVIDUAL DONOR TESTING THAN DURING PP6 TESTING. THIS IS BECAUSE THE LIMIT OF DETECTION OF THE MPX TEST DURING INDIVIDUAL DONOR TESTING FOR THE (B)(6) TARGET IS 11 IU/ML AND 66 IU/ML DURING PP6 TESTING. THE TND RESULT GENERATED WITH THE COBAS TAQMAN (B)(6) TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM INDICATES THAT IT IS BELOW THE LOD OF THE TEST, WHICH IS 20 IU/ML. GIVEN THAT MUTATIONS WITHIN THE HIGHLY CONSERVED REGIONS OF THE VIRAL GENOMES COVERED BY THE COBAS TAQSCREEN MPX TEST PRIMERS AND/OR PROBES ARE RARE, THE MOST LIKELY CAUSE FOR THE (B)(6) RESULTS IS THE PRESENCE OF A LOW (B)(6) TITER IN THE SAMPLE DURING PP6 TESTING. REVIEW OF CDC INTERPRETATION OF RESULTS OF TEST FOR (B)(6) AND FURTHER ACTIONS INDICATE THAT A TEST OUTCOME OF SEROLOGY (B)(6) NOT DETECTED IS INTERPRETED AS NO CURRENT (B)(6) AS THIS SCENARIO CAN OCCUR IN PATIENTS THAT HAVE HAD EXPOSURE AND/OR TREATMENT FOR (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 THE INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER IN (B)(6) ALLEGES THAT (B)(6) RESULTS WERE GENERATED USING THE COBAS TAQSCREEN MPX V 1.0 TEST USING POOLS OF 6. THERE IS NO INDICATION THAT RESOLUTION POOL OF 1 HAS BEEN RUN. (B)(6). THERE IS NO RAW DATA AVAILABLE NOR EXACT DATE OF TESTING OTHER THAN THE INFO THAT THE CUSTOMER IN (B)(6) RUN THE SAMPLE IN 'LAST JANUARY'. THE 'AFFECTED' BLOOD UNIT WAS NOT RELEASED FOR DONATION. THIS MDR WILL ADDRESS THE RESULTS OF SAMPLE # (B)(6). THE MDR 2243471-2014-00010 WILL ADDRESS THE RESULTS OF SAMPLE #(B)(6). THE MDR 2243471-2014-00012 WILL ADDRESS THE RESULTS OF SAMPLE #(B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221757 COBAS TAQSCREEN MPX TEST CE-IVD ASSAY,HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA, AND HBV DNA MZP ROCHE MOLECULAR SYSTEMS 122992

    Patients

    Seq Age Sex Outcome Treatment
    1