BEUDAMED
    FDA Adverse Event Summary report: N

    COBAS 4800 HPV TEST, CE-IVD

    MDR report key: 2492534 · Received March 15, 2012

    Report

    Report Number
    2243471-2012-00014
    Date Received
    March 15, 2012
    Date of Event
    February 14, 2012
    Report Date
    July 10, 2012
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO FAILURE DETECTED AND PRODUCT PERFORMED WITHIN SPECIFICATION. NO PRODUCT OR BATCH NON-CONFORMANCE WAS IDENTIFIED. UPON INVESTIGATION THERE WAS NO TREND FOUND IN THE FIELD. QC RELEASE DATA FOR P05296 WAS REVIEWED AND THE ISSUE OF DISCREPANT RESULTS HAS NOT BEEN OBSERVED. THERE HAVE NOT BEEN ANY MANUFACTURING NON-CONFORMANCE REPORTS FOR BATCH P05296. RETAIN TESTING OF THE COMPLAINT BATCH P05296 WAS TESTED FOR THIS CASE AND GENERATED VALID AND ACCEPTABLE RESULTS. ALTHOUGH REQUESTED, NO SAMPLES WERE RETURNED FOR EVALUATION. DURING THE COURSE OF THE CASE INVESTIGATION, THE CUSTOMER INDICATED THAT THEY DID NOT WISH TO PURSUE THE INVESTIGATION FOR THE ORIGINAL 5 SAMPLES AS THESE DISCREPANCIES WERE RESOLVED AT THE SITE. SAMPLE (B)(6) WAS RETESTED WITH THE COBAS 4800 HPV TEST ON-LABEL (I.E. UNDILUTED) AND GENERATED (B)(6) RESULTS WHICH CORRELATED WITH THE INITIAL AMPLICOR RESULTS OBTAINED AT THE SITE. SAMPLE (B)(6) WAS RETESTED WITH THE COBAS 4800 HPV TEST ON-LABEL (I.E. UNDILUTED) AND GENERATED (B)(6) RESULTS WHICH CORRELATED WITH THE INITIAL AMPLICOR RESULTS OBTAINED AT THE SITE. SAMPLE (B)(6) WAS NOT RETESTED USING THE COBAS 4800 HPV TEST AS NOT ENOUGH SAMPLE MATERIAL WAS LEFT TO PERFORM TESTING. THIS SAMPLE WAS TESTED AT A REFERENCE LAB AND ALSO GENERATED (B)(6) RESULTS WITH THE AMPLICOR HPV TEST, CORRELATING WITH THE INITIAL AMPLICOR RESULTS AT THE SITE. SAMPLE (B)(6) WAS NOT RETESTED USING THE COBAS 4800 HPV TEST AS NOT ENOUGH SAMPLE MATERIAL WAS LEFT TO PERFORM TESTING. THIS SAMPLE WAS TESTED AT A REFERENCE LAB AND GENERATED A (B)(6) RESULT ON THE AMPLICOR AND (B)(6) RESULT BY GENOTYPING. THESE RESULTS CORRELATED WITH THE COBAS 4800 HPV RESULTS GENERATED AT THE COMPLAINT SITE. SAMPLE (B)(6) WAS NOT RETESTED USING THE COBAS 4800 HPV TEST AS NOT ENOUGH SAMPLE MATERIAL WAS LEFT TO PERFORM TESTING. AN EXTRACT OF THIS SAMPLE WAS TESTED AT A REFERENCE LAB AND GENERATED A (B)(6) RESULT ON THE AMPLICOR AND (B)(6) RESULT BY GENOTYPING. THESE RESULTS CORRELATED WITH THE COBAS 4800 HPV RESULTS GENERATED AT THE COMPLAINT SITE. NO AMPLICOR (B)(4) DATA WAS PROVIDED FOR THE 5 ORIGINAL SAMPLES. ANALYSIS OF THE PROVIDED COBAS 4800 HPV TEST RAW DATA SHOWS THAT THE CT VALUES GENERATED FOR SAMPLES (B)(6) IN THE ORIGINAL AND RETEST OF THE DILUTED SAMPLES WERE NEAR THE LIMIT OF DETECTION FOR THE TEST, WHICH MAY CAUSE THESE SAMPLES TO WAIVER BETWEEN (B)(6) IF RETESTED (SAMPLING EFFECT). FURTHERMORE, DILUTING THESE SAMPLES MAY HAVE RESULTED IN A LOWER CONCENTRATION OF THE TARGET IN A SAMPLE THAT IS ALREADY KNOWN TO BE A LOW (B)(6). FURTHER INFORMATION WAS LATER PROVIDED THAT THERE WERE 3 ADDITIONAL SAMPLES: (B)(6), THAT WERE ALSO DISCREPANT BETWEEN THE COBAS 4800 HPV TEST AND THE AMPLICOR HPV TEST, BUT WERE PROCESSED ON-LABEL (PRESERVCYT SOLUTION NOT DILUTED WITH PCR MEDIA). NO COBAS 4800 HPV TEST DATA WAS PROVIDED FOR SAMPLES (B)(6). HOWEVER, DATA WAS PROVIDED FOR THE AMPLICOR TEST AT THE REFERENCE LAB AND SHOWS THAT ALL 3 SAMPLES WERE (B)(6). THE DISCREPANT RESULTS FOR THESE 3 SAMPLES MAY BE DUE TO THE DIFFERENCES IN SENSITIVITIES AND LIMIT OF DETECTION FOR EACH TEST. HOWEVER, AS THE COBAS 4800 HPV TEST DATA CANNOT BE ANALYZED THE TRUE CAUSE OF THE DISCREPANCIES IS UNKNOWN. (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. THE RELATED US-IVD COBAS 4800 HPV TEST IS M/N (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN (B)(6) ALLEGED DISCREPANT RESULTS WERE GENERATED WITH THE KIT COBAS 4800 HPV AMP/DET 240 T CE-IVD. SPECIFICALLY, THE CUSTOMER ALLEGED THAT DURING VALIDATION OF THE COBAS 4800, THEY GENERATED DISCREPANT RESULTS WHEN COMPARED TO THE AMPLICOR HPV TEST. THE CUSTOMER WAS DILUTING THE THINPREP SAMPLES IN A 1:1 RATION WITH THE COBAS PCR MEDIA WHICH IS AN OFF LABEL PRACTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 4800 HPV TEST, CE-IVD KIT, DNA DETECTION, HUMAN PAPILLOMA VIRUS MZP ROCHE MOLECULAR SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1