BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® AMPLIPREP/COBAS® TAQMAN® HBV TEST, V2.0 CE-IVD

    MDR report key: 2222041 · Received August 24, 2011

    Report

    Report Number
    2243471-2011-00076
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MKT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): METHOD: ANALYSIS OF LABELING AND (REVIEW OF DESIGN HISTORY DATA AND ANALYSIS OF RAW DATA FROM THE CUSTOMER SITE). RESULT: DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. CONCLUSION: NO FAILURE DETECTED AND PRODUCT PERFORMED WITHIN SPECIFICATION. NO PRODUCT OR BATCH NON-CONFORMANCE WAS IDENTIFIED. ANALYSIS OF THE RAW DATA DOES NOT SHOW ANY INDICATION OF AN ISSUE WITH THE COBAS AMPLIPREP/ COBAS TAQMAN SYSTEM (I.E. CURVE ANOMALIES, PIPETTING PROBLEMS, ETC.). UPON INVESTIGATION THERE WAS NO TREND FOUND IN THE FIELD. QC RELEASE DATA FOR N11158 WAS REVIEWED AND THE ISSUE OF DISCREPANT RESULTS HAS NOT BEEN OBSERVED. THERE HAVE NOT BEEN ANY MANUFACTURING NON-CONFORMANCE REPORTS FOR BATCH N11158. THE PACKAGE INSERT FOR THIS TEST INCLUDES A CORRELATION STUDY BETWEEN THE CAP-CTM HBV TEST AND THE VERSANT HBV DNA TEST. THE STUDY INCLUDES ONE SAMPLE WITH SIMILARLY DISCREPANT RESULTS (LOG 2 FOR CAP-CTM AND LOG 5 FOR VERSANT). REVIEW OF THE DESIGN HISTORY FILE FOR THIS STUDY SHOWS THAT THE STUDY SAMPLE WAS SEQUENCED AND HAD NO MISMATCHES THAT WOULD AFFECT THE CAP-CTM TEST. THE STUDY SAMPLE ALSO CORRELATED WELL BETWEEN CAP-CTM, ABBOTT, COBAS AMPLICOR AND HIGH PURE TESTS. THE STUDY SAMPLE WAS RETESTED WITH CAP-CTM AND THE SAME RESULTS WERE CONFIRMED. THERE ARE NO ADDITIONAL CONCLUSIONS MADE IN THE STUDY REGARDING THIS DISCREPANCY, HOWEVER, IT COULD BE THAT THE VERSANT TESTS OVER QUANTIFIES THIS SAMPLE. NO SAMPLE MATERIAL WAS AVAILABLE FROM THE CUSTOMER FOR INVESTIGATIVE TESTING TO CONFIRM THE PRESENCE OF ANY SEQUENCE MISMATCHES OR TO FURTHER EVALUATION THIS ISSUE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ISSUE IS UNDER INVESTIGATION. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) FILED A COMPLAINT ALLEGING THAT DISCREPANT HBV RESULTS WERE GENERATED FOR TWO SAMPLES WITH THE COBAS AMPLIPREP/COBAS TAQMAN (CAP/CTM) HBV V2.0 TEST WHEN COMPARED TO THE VERSANT BDNA TEST. THE RESULTS WITH ONE SAMPLE WERE (B)(6) WITH CAP/CTM HBV V2.0 AND (B)(6) WITH VERSANT BDNA. IT IS PLANNED TO OBTAIN SEQUENCING INFORMATION FOR THE SAMPLE. THE OTHER SAMPLE IS ADDRESSED IN MDR 2243471-2011-00077.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS® AMPLIPREP/COBAS® TAQMAN® HBV TEST, V2.0 CE-IVD HEPATITIS VIRAL B DNA DETECTION MKT ROCHE MOLECULAR SYSTEMS N18322

    Patients

    Seq Age Sex Outcome Treatment
    1