BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2

    MDR report key: 15447132 · Received September 19, 2022

    Report

    Report Number
    2243471-2022-00799
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    July 29, 2022
    Report Date
    September 19, 2022
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QJR
    PMA / PMN Number
    EUA210388
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CT VALUES OBSERVED IN THE POSITIVE CEPHEID AND LIAT RUNS FOR THESE 4 SAMPLES ARE INDICATIVE OF A SAMPLE NEAR THE LIMIT OF DETECTION FOR THE CEPHEID ASSAY BASED ON THE VALUE PUBLISHED IN THEIR PACKAGE INSERT. THE OBSERVED DISCREPANCY IS MOST LIKELY DUE TO THE SAMPLE BEING A WEAK POSITIVE FOR THE SARS-COV-2 TARGET THAT IS AT/NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY. VERY LOW VIRAL LOAD SPECIMENS THAT ARE NEAR THE ASSAY LOD MAY NOT GENERATE CONSISTENT RESULTS UPON REPEAT TESTING ACCORDING TO EXPECTED STATISTICAL VARIANCES IN DETECTION. THIS IS A SAMPLE-SPECIFIC ISSUE AND THE REAGENT IS PERFORMING AS EXPECTED.

    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 THE UNITED STATES ALLEGED DISCREPANT RESULTS FOR FOUR PATIENTS WHILE USING THE COBAS SARS-COV-2 NUCLEIC ACID TEST FOR USE ON THE COBAS LIAT SYSTEM. PATIENT 1 AND 2: THE SAMPLE (ONE FOR EACH PATIENT) WAS INITIALLY TESTED TWICE ON THE SAME DAY AND ON THE SAME COBAS LIAT ANALYZER AND GENERATED A NEGATIVE RESULT FOR SARS-COV-2 EACH TIME. A RETEST OF THE SAME SAMPLE ON A COMPETITOR PLATFORM (CEPHEID) GENERATED A POSITIVE RESULT FOR SARS-COV-2. ALL TESTING WAS PERFORMED THE SAME DAY. PATIENT 3: THE SAMPLE WAS TESTED ON CEPHEID AND GENERATED A POSITIVE RESULT FOR SARS-COV-2. THE SAME SAMPLE WAS REPEATED TWICE ON THE SAME COBAS LIAT ANALYZER AND GENERATED A NEGATIVE RESULT EACH TIME. ANOTHER TEST OF THE SAME SAMPLE ON CEPHEID ALSO GENERATED A NEGATIVE RESULT. ALL TESTING WAS PERFORMED THE SAME DAY. PATIENT 4: THE SAMPLE TESTED ON CEPHEID GENERATED A POSITIVE RESULT FOR SARS-COV-2. THE NEXT DAY THE SAME SAMPLE WAS TESTED ON COBAS LIAT AND GENERATED A NEGATIVE RESULT FOR SARS-COV-2. A RETEST THE FOLLOWING DAY OF THE SAME SAMPLE ON CEPHEID GENERATED A POSITIVE RESULT FOR SARS-COV-2 AND A NEGATIVE RESULT FOLLOWED BY A POSITIVE RESULT ON TWO FURTHER RETESTS ON COBAS LIAT. NO HARM WAS ALLEGED. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER ISSUE. PER FDA¿S EUA GUIDANCE, 4 MDR WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372670 COBAS® SARS-COV-2 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 20321U

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown