BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 4800 HPV TEST

    MDR report key: 6719047 · Received July 17, 2017

    Report

    Report Number
    2243471-2017-00019
    Event Type
    Malfunction
    Date Received
    July 17, 2017
    Date of Event
    February 22, 2017
    Report Date
    November 17, 2017
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MAQ
    PMA / PMN Number
    P100020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM (B)(6) OBSERVED INTER-ASSAY DISCREPANT RESULTS FOR A PATIENT SAMPLE TESTED WITH COBAS 4800 (B)(6) TEST AND NON-ROCHE ASSAY (DIGENE). RESULTS GENERATED ON COBAS 4800 WERE (B)(6), WHEREAS THE NON-ROCHE ASSAY GENERATED (B)(6) POSITIVE RESULTS. FURTHERMORE, CYTOLOGY RESULTS SHOWED HIGH GRADE LESIONS. THIS TESTING WAS PART OF AN EVALUATION OF THE COBAS 4800 TEST AT A CUSTOMER SITE. NO RESULT ON THE COBAS 4800 TEST WAS REPORTED TO THE PATIENT. DURING THE INVESTIGATION, THE SAMPLE WAS RETURNED FOR FURTHER INVESTIGATION. INVESTIGATIVE TESTING DID NOT REPRODUCE ALLEGATION. RESULTS FROM THE COBAS 4800 (B)(6) TEST AND SEQUENCE ANALYSIS BOTH SHOW (B)(6) RESULTS FOR HIGH RISK (B)(6) GENOTYPES. DESPITE SEVERAL ATTEMPTS TO OBTAIN A (B)(6) SEQUENCE FROM THE SAMPLE, NO VIRAL SEQUENCE WAS OBTAINED. THE LACK OF (B)(6) SEQUENCE DOES NOT NECESSARILY MEAN THAT NO HIGH RISK (B)(6) VIRUS IS PRESENT IN THE SAMPLE. THE LACK OF SEQUENCE INFORMATION COULD BE DUE TO SEQUENCE HETEROGENEITY UNDER THE PRIMERS USED FOR SEQUENCING, AN INHIBITOR, OR DUE TO LOW TITERS. THE LEFT OVER ELUATE WAS FURTHER TESTED USING THE ROCHE LINEAR ARRAY (B)(6) GENOTYPING TEST, WHICH DETECTS 37 HIGH AND LOW RISK (B)(6) GENOTYPES. THE LINEAR ARRAY (B)(6) RESULT ALSO GENERATED A (B)(6) RESULT. FROM THE INTERNAL INVESTIGATION PERFORMED ON THE COBAS 4800 (B)(6) TEST, NO RELATED ISSUES TO THE CUSTOMER ALLEGATION WERE IDENTIFIED.

    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 KIT COBAS 4800 (B)(6) AMP/DET 240T CE-IVD IS (B)(4). (B)(4). THE CORRESPONDING US KIT MATERIAL NUMBER IS (B)(4). PMA# P100020.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) OBSERVED INTER-ASSAY DISCREPANT RESULTS FOR A PATIENT SAMPLE TESTED WITH COBAS 4800 (B)(6) TEST AND NON-ROCHE ASSAY (DIGENE). RESULTS GENERATED ON COBAS 4800 WERE (B)(6) FOR (B)(6), WHEREAS THE NON-ROCHE ASSAY GENERATED (B)(6) RESULTS. FURTHERMORE, CYTOLOGY RESULTS SHOWED HIGH GRADE LESIONS. THIS WAS PART OF AN EVALUATION OF THE COBAS 4800 TEST AT A CUSTOMER SITE. NO RESULT ON THE COBAS 4800 TEST WAS REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500395 COBAS 4800 HPV TEST KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS MAQ ROCHE MOLECULAR SYSTEMS NA X09600

    Patients

    Seq Age Sex Outcome Treatment
    1