BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBAS HPV TEST, US-IVD

    MDR report key: 7503154 · Received May 10, 2018

    Report

    Report Number
    2243471-2018-00006
    Event Type
    Injury
    Date Received
    May 10, 2018
    Date of Event
    April 11, 2018
    Report Date
    July 11, 2018
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC.
    Product Code
    MAQ
    PMA / PMN Number
    P100020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A US CUSTOMER ALLEGED THE GENERATION OF A FALSE NEGATIVE HPV RESULT WITH THE COBAS 4800 HPV TEST, FOR A PATIENT SAMPLE THAT DEMONSTRATED A LARGE, RAPIDLY GROWING SQUAMOUS CELL CARCINOMA (SCC), AND WAS P16 POSITIVE BY IMMUNOHISTOCHEMISTRY AND FOR HPV WITH AN E6/E7 RNA ISH TEST. REVIEW OF THE PROVIDED COBAS 4800 HPV TEST DATA FOR THE PROBLEMATIC SAMPLE INDICATED THAT THERE WERE NO ANOMALOUS GROWTH CURVES; THE KIT CONTROLS INCLUDED WITHIN THE RUNS GENERATED EXPECTED RESULTS. NO ISSUES WERE IDENTIFIED DURING QC KIT RELEASE FOR THE COMPLAINT COBAS 4800 HPV TEST (LOT Y20292), AND THERE WERE NO RELATED INTERNAL NON-CONFORMANCES. ALTHOUGH REQUESTED, THE PATIENT SAMPLE WAS NOT RETURNED FOR FURTHER INVESTIGATION. POSSIBLE CAUSES OF THE DISCREPANT RESULTS ALLEGED AND NEGATIVE COBAS 4800 HPV RESULTS INCLUDE: 1 - THE SQUAMOUS CELL CARCINOMA (SCC) WAS NOT CAUSED BY AN HPV VIRAL INFECTION; 2 - THE SCC WAS CAUSED BY AN HPV VIRAL INFECTION, BUT NOT BY ONE OF THE HPV GENOTYPES COVERED BY THE COBAS 4800 HPV ASSAY. 3- THERE COULD BE PROBE/PRIMER MISMATCHES PRESENT IN THE SAMPLE THAT MAY RESULT IN THE FAILURE TO DETECT THE PRESENCE OF HPV IN THE PATIENT SAMPLE WITH THE COBAS 4800 HPV TEST. THE COBAS 4800 HPV INSTRUCTIONS FOR USE INDICATES "THOUGH RARE, MUTATIONS WITHIN THE HIGHLY CONSERVED REGIONS OF THE GENOMIC DNA OF HUMAN PAPILLOMAVIRUS COVERED BY THE COBAS® HPV TEST¿S PRIMERS AND/OR PROBES MAY RESULT IN FAILURE TO DETECT THE PRESENCE OF THE VIRAL DNA." (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THIS ISSUE IS CURRENTLY ON-GOING. THE OUTCOME OF THIS INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. THE UDI FOR THE COBAS 4800 HPV AMP/DET 960T US-IVD IS (B)(4).

    Description of Event or Problem · 1

    A US CUSTOMER ALLEGED THE GENERATION OF A (B)(6) RESULT WITH THE COBAS 4800 HPV TEST, FOR A PATIENT SAMPLE THAT DEMONSTRATED A LARGE, RAPIDLY GROWING SQUAMOUS CELL CARCINOMA (SCC), AND WAS (B)(6) BY IMMUNOHISTOCHEMISTRY AND FOR (B)(6) WITH AN (B)(6) RNA ISH TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345028 COBAS HPV TEST, US-IVD HUMAN PAPILLOMAVIRUS DNA DETECTION KIT MAQ ROCHE MOLECULAR SYSTEMS, INC. NA Y20292

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other