BEUDAMED
    FDA Adverse Event Summary report: N

    COBAS 4800 HPV TEST, CE-IVD

    MDR report key: 2568748 · Received May 10, 2012

    Report

    Report Number
    2243471-2012-00021
    Date Received
    May 10, 2012
    Date of Event
    April 3, 2012
    Report Date
    May 25, 2012
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MAQ
    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. THE OUTCOME OF THE INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. THE RELATED US-IVD COBAS 4800 (B)(6) TEST IS (B)(6). PMA P100020. (B)(4).

    Additional Manufacturer Narrative · 1

    FOLLOW UP REPORT 1. ADDITIONAL INFORMATION / DEVICE EVALUATION. DEVICE EVALUATED BY MANUFACTURER YES. THE CUSTOMER ALLEGED THAT 2 PATIENT SAMPLES GENERATED DISCREPANT RESULTS WITH THE COBAS 4800 HPV AMP/DET 240T CE-IVD TEST AS COMPARED TO A COMPARATOR TEST (DIGENE-QIAGEN) FOR (B)(6)DETECTION. THIS REPORT IS FOR SAMPLE NUMBER (B)(4), MDR 2243471-2012-00022 WAS FILED FOR SAMPLE NUMBER (B)(4). SPECIFICALLY THE COBAS 4800 HPV AMP/DET 240T CE-IVD GENERATED (B)(6)RESULTS FOR (B)(6) AND OTHER HIGH RISK (B)(6) AND THE COMPARATOR TEST GENERATED (B)(6) RESULTS FOR (B)(6) AND OTHER HIGH RISK (B)(6). INVESTIGATIVE TESTING OF THE COMPLAINT SAMPLE USING THE COBAS 4800 HPV TEST GENERATED THE SAME VALID (B)(6) RESULTS AS REPORTED BY THE CUSTOMER. KIT BATCH RETAIN TESTING MET SPECIFICATION. THE HIGH PURE (B)(6) DNA TEST BY DIGENE- QIAGEN IS A NUCLEIC ACID HYBRIDIZATION ASSAY WITH SIGNAL AMPLIFICATION THAT UTILIZES MICROPLATE CHEMILUMINESCENT DETECTION. THIS UNIT OF MEASURE USES THE AMOUNT OF EMITTED LIGHT AND IS MEASURED AS RELATIVE LIGHT UNITS (RLUS) ON A LUMINOMETER. THE INTENSITY OF THE LIGHT EMITTED DENOTES THE PRESENCE OR ABSENCE OF TARGET DNA IN THE SPECIMEN. THE COBAS 4800 HPV TEST USES REAL TIME PCR TECHNOLOGY AND MEASURES THE FLUORESCENCE EMITTED OF THE POLYMERASE CHAIN REACTION. THE NUMBER OF CYCLES AT WHICH THE RELATIVE FLUORESCENCE EXCEEDS THE THRESHOLD IS THE THRESHOLD CYCLE (CT). THESE TWO UNITS OF MEASURE ARE NOT DIRECTLY COMPARABLE. THE HYBRID CAPTURE HPV DNA TEST MEASURES ITS LIMIT OF DETECTION IN PG/ML (A UNIT OF MASS DENSITY) AND THE COBAS 4800 HPV TEST MEASURES ITS LIMIT OF DETECTION IN COPIES /ML (A UNIT OF VIRAL LOAD). THESE TWO UNITS AND TEST RESULTS ARE NOT DIRECTLY COMPARABLE. THE DIFFERENCES SEEN BETWEEN THE ASSAYS COULD BE DUE, BUT NOT LIMITED TO, SENSITIVITY DIFFERENCES BETWEEN THE TESTS, THE ABILITY OF THE DIGENE-QIAGEN TEST TO DETECT LOW RISK HPV GENOTYPES , AND SAMPLE COLLECTION METHODS. THE COBAS 4800 HPV TEST PERFORMED AS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN (B)(6) IS ALLEGING DISCREPANT RESULTS WERE GENERATED WITH THE COBAS 4800 HPV AMP/DET 240T CE-IVD AND A COMPARATOR TEST (DIGENE-QIAGEN) FOR (B)(6) DETECTION. SPECIFICALLY THE COBAS 4800 HPV AMP/DET 240T CE-IVD GENERATED NEGATIVE RESULTS FOR (B)(6) AND OTHER HIGH RISK (B)(6) AND THE COMPARATOR TEST GENERATED (B)(6) RESULTS FOR (B)(6), AND OTHER HIGH RISK (B)(6). THE SAMPLE WAS FIRST TESTED ON (B)(6) 2012 AND REPEAT TESTING WAS PERFORMED ON (B)(6) 2012. THE REPEAT TEST CONFIRMED THE ORIGINAL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 4800 HPV TEST, CE-IVD KIT, DNA DETECTION, HUMAN PAPILLOMA VIRUS MAQ ROCHE MOLECULAR SYSTEMS P09699

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR