BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS SARS-COV-2 TEST - 480T

    MDR report key: 12167613 · Received July 14, 2021

    Report

    Report Number
    2243471-2021-02461
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 14, 2021
    Report Date
    July 14, 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
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM (B)(6) REPORTED SEVERAL FALSE POSITIVE SARS-COV-2 RESULTS WHILE USING THE COBAS 6800/8800 SARS-COV-2 TEST. A TOTAL OF FOUR BATCH MDRS ARE BEING SUBMITTED REPRESENTING 55 SAMPLES. EACH BATCH WILL REPRESENT ONE EVENT ON A SINGLE DEVICE ASSOCIATED WITH COMPLAINT CASE (B)(4), AS NO UNIQUE PATIENT INFORMATION WAS PROVIDED AS PER FDA GUIDANCE ((B)(6)). RUN BATCH NO. 1 TESTED A TOTAL OF 8 SAMPLES. RUN BATCH NO. 2 TESTED A TOTAL OF 22 SAMPLES. RUN BATCH NO. 3 TESTED A TOTAL OF 2 SAMPLES AND RUN BATCH NO. 4 TESTED A TOTAL OF 23 SAMPLES. ALL SAMPLES TESTED POSITIVE FOR SARS-COV-2 TARGETS OF THE ASSAY. NO HARM WAS ALLEGED. IT WAS REPORTED THAT THE CUSTOMER SUSPECTED CONTAMINATION OF THE INSTRUMENT AND THEREFORE CLEAN-UP MAINTENANCE ACTIONS, SEVERAL PRIMING, REPLACEMENT OF ALL CONSUMABLES AND REAGENTS, AS WELL AS DECONTAMINATION OF SAMPLE RACKS, SAMPLE RACK TRAYS, AND WORKING AREA WAS PERFORMED. SUBSEQUENTLY, RUNS OF KNOWN NEGATIVE SAMPLES WERE PERFORMED WHICH SHOWED THE EXPECTED NON-REACTIVE RESULTS. THE INSTRUMENT IS WORKING AS EXPECTED. ADDITIONALLY, FROM THE ANALYSIS OF THE LOG FILES PROVIDED, NO SYSTEMATIC ISSUE HAS BEEN FOUND. THE CUSTOMER ISSUE HAS BEEN ALLEGED ON THE COBAS 8800 INSTRUMENT, PRODUCT CODE MZA, CATALOG NUMBER 05412722001 AND UDI (B)(4). THE TEST USED ON THE COBAS 68/8800 SYSTEM IS THE KIT COBAS 6800/8800 SARS-COV-2 480T ASSAY PRODUCT CODE QJR, CATALOG NUMBER 09343733190 AND UDI (B)(4). THIS MDR IS SUBMITTED AGAINST THE KIT COBAS 6800/8800 SARS-COV-2 480T (PRODUCT CODE: QJR) INSTEAD OF THE COBAS 68/8800 SYSTEM, PER FDA REQUEST. (B)(4).

    Description of Event or Problem · 0

    IN LIGHT OF THE COVID-19 PANDEMIC AND THE SUBSEQUENT EMERGENCY USE AUTHORIZATIONS (EUAS) FOR SARS-COV-2 DIAGNOSTIC TESTS, THE AGENCY HAS REQUESTED HEIGHTENED REPORTING BEYOND THE REASONABLY SUGGESTS REQUIREMENTS OF 803 TO INCLUDE ALLEGATIONS OF FALSE POSITIVE OR FALSE NEGATIVE RESULTS INDEPENDENT OF HARM OR MALFUNCTION OR OFF-LABEL USE. PURSUANT TO THE AGENCY¿S INSTRUCTION, WE HEREBY SUBMIT THIS MDR. A CUSTOMER FROM (B)(6) ALLEGED AN INCREASE IN POSITIVE RESULTS WITH THE WITH COBAS SARS-COV-2 QUALITATIVE ASSAY ON THE COBAS 6800/8800 SYSTEM SN (B)(4). SOME OF THE SAMPLES IN QUESTION WERE RETESTED ON ANOTHER COBAS 6800/8800 SYSTEMS AND RETURNED NEGATIVE RESULTS FOR ALL TARGETS. 55 PATIENT SAMPLES GENERATED A POSITIVE RESULT FOR SARS-COV-2 DURING INITIAL TESTING. THE 55 ALLEGED SAMPLES WERE TESTED WITHIN 4 DIFFERENT RUN BATCHES. RUN BATCH NO. 1 TESTED 8 SAMPLES. RUN BATCH NO. 2 TESTED 22 SAMPLES. RUN BATCH NO. 3 TESTED 2 SAMPLES AND RUN BATCH NO. 4 TESTED 23 SAMPLES. ALL SAMPLES TESTED POSITIVE FOR SARS-COV-2 TARGETS OF THE ASSAY. THERE IS NO INFORMATION IF ALL 55 ALLEGED SAMPLES WERE RECOLLECTED FOR RE-TESTS AND RETESTED ON ANOTHER PLATFORM. HOWEVER, PER ADDITIONAL INFORMATION, THE SAMPLES WHICH WERE RE-TESTED ON A DIFFERENT PLATFORM TESTED NEGATIVE FOR ALL TARGETS. NO HARM WAS ALLEGED. WITH THE AVAILABLE INFORMATION, A LIMITED INVESTIGATION WAS CONDUCTED AND NO PRODUCT PROBLEM WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062466 COBAS SARS-COV-2 TEST - 480T REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA H01397

    Patients

    Seq Age Sex Outcome Treatment
    1