BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBAS 4800 HPV TEST

    MDR report key: 6450462 · Received March 31, 2017

    Report

    Report Number
    2243471-2017-00007
    Event Type
    Injury
    Date Received
    March 31, 2017
    Date of Event
    March 6, 2017
    Report Date
    May 16, 2017
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MAQ
    PMA / PMN Number
    P100020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A (B)(6) CUSTOMER REPORTED THE GENERATION OF DISCREPANT (B)(6) RESULTS FOR A PATIENT BETWEEN THE COBAS 4800 HPV TEST (B)(6) AND OTHER TESTS (B)(6). A BIOPSY FROM (B)(6) 2016 SHOWED HIGH-GRADE SQUAMOUS INTRAEPITHELIAL LESION (HSIL) AND SQUAMOUS CELL CANCER. THE SAMPLE FROM (B)(6) 2016 WAS SENT TO ROCHE FOR SEQUENCING ANALYSIS. THE SAMPLE WAS SUBJECTED TO SEQUENCING USING ALL PGMY PRIMERS AND (B)(6) TYPE 16 SPECIFIC PRIMERS. PGMY WOULD CONFIRM THE PRESENCE OF (B)(6) IN THE SAMPLE WHILE THE TYPE SPECIFIC PRIMERS WOULD GENERATE SEQUENCE INFORMATION UNDER THE ASSAY OLIGOS BINDING SITES. DIFFERENT VOLUME INPUTS, NUMBER OF CYCLES WERE TESTED TO INCREASE THE PROBABILITY OF OBTAINING THE TARGETED AMPLICON. DESPITE SEVERAL ATTEMPTS TO OBTAIN (B)(6) SEQUENCES FROM THE SAMPLES, NO VIRAL SEQUENCES WERE OBTAINED. THE LACK OF (B)(6) SEQUENCE DOES NOT NECESSARILY MEAN THAT NO (B)(6) WAS PRESENT IN THE SAMPLES. THE LACK OF SEQUENCE INFORMATION COULD BE DUE TO INHIBITORY FACTORS THAT HAVE A (B)(6) IMPACT TO THE COBAS HPV ASSAY PERFORMANCE OR THE SEQUENCE HETEROGENEITY AFFECTING THE PRIMERS USED FOR SEQUENCING. FROM THE INTERNAL INVESTIGATION PERFORMED ON THE PRODUCT, NO RELATED ISSUES TO THE CUSTOMER ALLEGATION WERE IDENTIFIED. AFTER FILING THE INITIAL MDR REPORT, INFORMATION WAS PROVIDED, SPECIFICALLY RELATING TO THE PATIENT AND THE INITIAL REPORTER. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THE CASE ISSUE IS ON-GOING. A SUPPLEMENTATION REPORT WILL BE PROVIDED AT THE END OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    (B)(6) CUSTOMER REPORTED THE GENERATION OF DISCREPANT (B)(6) RESULTS FOR A PATIENT BETWEEN THE COBAS 4800 HPV TEST ((B)(6)) AND OTHER TESTS ((B)(6)). SAMPLES (DIFFERENT COLLECTIONS) WERE TESTED FOR THE SAME PATIENT IN (B)(6) 2015 AND (B)(6) 2016. ALL RESULTS GENERATED WITH THE COBAS 4800 HPV TEST WERE (B)(6), ((B)(6) 2016). RECENT TESTING ((B)(6) 2016) USING OTHER TESTS (SEEGENE ANYPLEX II HPV28 TEST; GENXPERT HPV TEST; "IN-HOUSE" PROTOCOL) GENERATED (B)(6) RESULTS. A BIOPSY FROM (B)(6) 2016 SHOWED HIGH-GRADE SQUAMOUS INTRAEPITHELIAL LESION (HSIL) AND SQUAMOUS CELL CANCER. IT IS NOT KNOWN IF THE PATIENT HAD CANCER IN (B)(6) 2015, WHEN SHE WAS ORIGINALLY TESTED (B)(6) WITH THE COBAS 4800 HPV TEST. ROCHE HAS REQUESTED REMAINING SAMPLE TO PERFORM FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232814 COBAS 4800 HPV TEST KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS MAQ ROCHE MOLECULAR SYSTEMS NA X08046

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other