BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS HPV TEST

    MDR report key: 11917879 · Received June 1, 2021

    Report

    Report Number
    2243471-2021-01545
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    March 30, 2021
    Report Date
    August 9, 2021
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC.
    Product Code
    MAQ
    PMA / PMN Number
    P100020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO ISSUES WERE IDENTIFIED WITH THE COMPLAINT KIT LOTS (F28427, F22328 AND G32187) DURING THE COURSE OF THE INVESTIGATION. ALTHOUGH REQUESTED, THE PATIENT'S PRESERVCYT SAMPLES AND HISTOLOGICAL SLIDES WERE NOT RETURNED FOR FURTHER EVALUATION AND INVESTIGATION. IT IS PLAUSIBLE THAT THE REPORTED CARCINOMA IS NOT HPV DRIVEN, WHICH SUPPORTS WHY THE COBAS HPV TEST GENERATED NEGATIVE HPV RESULTS. THIS HYPOTHESIS WOULD REQUIRE FURTHER TESTING OF THE SPECIMENS, WHICH WERE NOT PROVIDED AS NOTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ON-GOING. A SUPPLEMENTAL MDR WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. FACILITY NAME: (B)(6). (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) IS ALLEGING THE GENERATION OF (B)(6) HPV RESULTS FOR A PATIENT TESTED WITH THE COBAS 4800 HPV TEST AND A HOMEBREW ASSAY. SAMPLES COLLECTED FROM THIS PATIENT IN 2020 AND 2021, USING PRESERCYT COLLECTION MEDIA, ARE (B)(6) FOR OTHER HIGH RISK (HR) HPV, HPV16, AND HPV18, WHILE THE CUSTOMER'S HOMEBREW ASSAY DETECTED HPV52 (2021). IN 2021, THE CYTOLOGY REPORT FOR THIS PATIENT INDICATED HSIL (HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION), A BIOPSY SHOWED NON-KERATINIZING SPINAL CELL CARCINOMA WITH SIGNS OF INVASION, AND THERE WAS THE PRESENCE OF A TUMOR (+/- 5CM) ON THE UTERINE CERVIX. THE INVESTIGATION IS ON-GOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814476 COBAS HPV TEST HUMAN PAPILLOMAVIRUS DNA DETECTION KIT MAQ ROCHE MOLECULAR SYSTEMS, INC. NA F28427

    Patients

    Seq Age Sex Outcome Treatment
    1