BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM

    MDR report key: 11175459 · Received January 14, 2021

    Report

    Report Number
    2243471-2021-00068
    Event Type
    Malfunction
    Date Received
    January 14, 2021
    Date of Event
    December 18, 2020
    Report Date
    February 16, 2021
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QJR
    PMA / PMN Number
    EUA201779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. A FOLLOW-UP MDR WILL BE SUBMITTED TO PROVIDE THE OUTCOME OF THE INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    REVIEW OF THE RAW DATA SHOWED THAT PATIENT 1 SAMPLE PRODUCED A SARS POSITIVE RESULT WITH A CT OF 33.5 AND PATIENT 2 SAMPLE PRODUCED A POSITIVE SARS RESULT WITH A CT OF 36.2. THE CT VALUE OF THE PATIENT 2 SAMPLE IS INDICATIVE THE SAMPLE WAS AT THE LOD (LIMIT OF DETECTION) OF THE TEST AND PATIENT 1 SAMPLE LOOKS TO BE TRULY POSITIVE. THE CURVES WERE REVIEWED AND NO CURVE ABNORMALITIES WERE SEEN. THE SAMPLE THAT THE CUSTOMER WAS LATER DOING THE COMPARISON TESTING WAS ONE OF THE SAME PATIENT SAMPLES ALREADY TESTED. NO RESULT WAS REPORTED OUT AND NO HARM ALLEGED. INVESTIGATION ON THE REAGENT KIT DID NOT IDENTIFY ANY PRODUCT PROBLEM. WHILE THE COBAS® SARS-COV-2 & INFLUENZA A/B ASSAY AND THE DIASORIN LIAISON MDX ASSAY BOTH COVER THE ORF1 A/B NON-STRUCTURAL REGION OF SARS-COV-2, IT IS IMPORTANT TO NOTE THAT THE DIASORIN DETECTS 2 SPECIFIC REGIONS: THE S GENE ENCODES THE SPIKE GLYCOPROTEIN OF THE SARS-COV-2 (COVID-19 VIRUS), WHILE THE ORF1AB REGION ENCODES WELL-CONSERVED NONSTRUCTURAL PROTEINS. FURTHERMORE, THE NEW MUTATED VARIANT OF SARS-COV-2 IN GREAT BRITAIN VIRUS B1.1.7 H IS A MUTATION IN THE S-GENE. THEREFORE, IT CAN BE EXPECTED THAT IF THESE SAMPLES WERE PATIENTS INFECTED WITH THE NEW VARIANT, THE DIASORIN RESULTS WOULD BE AFFECTED. ADDITIONALLY, THE COBAS® SARS-COV-2 & INFLUENZA A/B ASSAY IS MORE CLINICALLY SENSITIVE THAN THE DIASORIN LIAISON MDX ASSAY. OVERALL, NO REAGENT ISSUE IS IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    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 US ALLEGED TWO PATIENT SAMPLES GENERATED POSITIVE SARS COV-2 RESULTS AND NEGATIVE FLU A AND FLU B RESULTS WHEN INITIALLY TESTED ON THE COBAS LIAT SYSTEM. BOTH SAMPLES WERE RETESTED ON TWO DIFFERENT COBAS LIAT SYSTEMS AND GENERATED THE SAME RESULTS. CUSTOMER RE-TESTED THE SAME PATIENT SAMPLES ON THEIR BACKUP METHOD, DIASORIN LIAISON MDX, AND BOTH PATIENTS GENERATED NEGATIVE RESULTS FOR SARS COV-2, FLU A AND FLU B. RESULTS OF THESE 2 PATIENT SAMPLES WERE REPORTED OUT AS SARS COV-2 POSITIVE. NO HARM INDICATED. IN ADDITION, CUSTOMER WAS COMPARING THE PERFORMANCE OF THE COBAS LIAT SARS-COV-2/FLU TEST ON THE COBAS LIAT SYSTEM TO THE DIASORIN LIAISON MDX INSTRUMENT. A SAMPLE GENERATED A POSITIVE RESULT WHEN TESTED ON THE COBAS LIAT SYSTEM. RETEST OF THE SAME SAMPLE ON THE DIASORIN LIAISON MDX INSTRUMENT GENERATED A NEGATIVE RESULT. THE SAMPLE WAS TESTED A THIRD TIME ON THE LIAT SYSTEM, AND THE SAMPLE WAS POSITIVE AGAIN. NO FURTHER INFORMATION WAS PROVIDED ON THIS SAMPLE USED FOR COMPARISON TESTING. TWO (2) MDRS, ONE PER EACH REPORTED PATIENT RESULT, WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71337 COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 00617Z

    Patients

    Seq Age Sex Outcome Treatment
    1