BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS SARS-COV-2 TEST

    MDR report key: 11212557 · Received January 22, 2021

    Report

    Report Number
    2243471-2021-00164
    Event Type
    Malfunction
    Date Received
    January 22, 2021
    Date of Event
    August 3, 2020
    Report Date
    January 21, 2021
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QJR
    PMA / PMN Number
    EUA200009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER FACILITY NAME TRUNCATED DUE TO CHARACTER LIMIT: (B)(6). A CUSTOMER ALLEGED UNEXPECTED PRESUMPTIVE POSITIVE RESULTS WITH THE COBAS® SARS-COV-2 TEST. 4 SAMPLES GENERATED POSITIVE RESULTS FOR TARGET 2 BUT RETURNED NEGATIVE RESULTS WITH ADDITIONAL TESTING. A REVIEW OF THE DATA INDICATED THE CUSTOMER WAS USING AN OUTDATED VERSION OF COBAS® 6800/8800 SYSTEMS ASAPS FOR THE COBAS® SARS-COV-2 TEST. AS THE CT VALUE WAS WITHIN THE PREDETERMINED RANGE, THE ALGORITHM FUNCTIONED AS INTENDED AND APPROPRIATELY CALLED THE SAMPLE POSITIVE. THE ALGORITHM SETTING HAS BEEN OPTIMIZED TO ACCOUNT FOR ADDITIONAL REAL WORLD DATA WITH IMPROVEMENT ON THE CURVE CLASSIFICATION PARAMETERS. (B)(4).

    Description of Event or Problem · 1

    THE AGENCY HAS CLARIFIED ITS EXPECTATION THAT MANUFACTURERS OF EMERGENCY USE AUTHORIZATION (EUA) PRODUCTS FOR SARS-COV-2 DIAGNOSTIC TESTS REPORT ALLEGATIONS OF FALSE POSITIVE OR FALSE NEGATIVE RESULTS INDEPENDENT OF HARM OR MALFUNCTION OR OFF-LABEL USE BEYOND 803¿S REASONABLY SUGGESTS REQUIREMENTS. ACCORDINGLY, WE HAVE PERFORMED A RETROSPECTIVE REVIEW OF CASES TO DETERMINE WHETHER TO REPORT ANY ADDITIONAL CASES. A CUSTOMER FROM (B)(6) ALLEGED UNEXPECTED PRESUMPTIVE POSITIVE RESULTS WITH THE COBAS® SARS-COV-2 TEST. 4 PATIENT SAMPLES ORIGINALLY GENERATED TARGET 2 POSITIVE RESULTS, BUT WERE NEGATIVE UPON RETESTING WITH THE GENEEXPERT ASSAY. ADDITIONALLY, PATIENT SAMPLE 2 WAS REPEATED ON THE COBAS® SARS-COV-2 TEST WHICH LIKEWISE GENERATED A NEGATIVE. NO INFORMATION REGARDING SAMPLE COLLECTION AND PREPARATION IS CURRENTLY AVAILABLE. A REVIEW OF THE GROWTH CURVES SHOWED A RELATIVELY FLAT CURVE WITH A SLIGHT RISE IN FLUORESCENCE AT THE BEGINNING OF THE BASELINE THAT CAUSED THE CT VALUE TO BE DETERMINED. AS THE CT VALUE WAS WITHIN THE PREDETERMINED RANGE, THE ALGORITHM FUNCTIONED AS INTENDED AND APPROPRIATELY CALLED THE SAMPLE POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112110 COBAS SARS-COV-2 TEST REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA G12165

    Patients

    Seq Age Sex Outcome Treatment
    1