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: 11735020 · Received April 27, 2021

    Report

    Report Number
    2243471-2021-01017
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    March 31, 2021
    Report Date
    April 27, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DATA ASSOCIATED WITH THE PATIENT SAMPLE AND CAN CONFIRM A POSITIVE FLU A RESULT WAS GENERATED WITH CT=35.9 NEAR THE CUTOFF AND LOW AMPLIFICATION CONSISTENT WITH SAMPLES NEAR THE LIMIT OF DETECTION (LOD). THIS RUN SHOWS NO ABNORMALITIES IN THE PCR CURVES. IT IS POSSIBLE THAT THIS RESULT CONTAINS VIRAL MATERIAL NEAR THE LOD OF THE ASSAY. THERE IS NO INDICATION OF AN ANALYZER ISSUE. THE LOD AND THE TYPE OF INFLUENZA VIRAL STRAINS DETECTED DIFFERS SIGNIFICANTLY BETWEEN THE SCFA ASSAY ON THE COBAS® LIAT® SYSTEM AND THE CEPHEID GENEXPERT ASSAYS. AS SUCH, RESULTS WITH ONE ASSAY MAY NOT BE REPRODUCIBLE WITH A DIFFERENT ASSAY. (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 IN THE UNITED STATES REPORTED DISCREPANT RESULTS WHILE USING THE COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM (LOT 01123Y, SN (B)(4)). IT WAS REPORTED THAT A SAMPLE GENERATED A POSITIVE RESULT FOR FLU A. THE SAME SAMPLE WAS RE-RUN ON A CEPHEID AND GENERATED NEGATIVE RESULTS. THE RESULTS WERE NOT REPORTED FOR FLU A. THE SAMPLE WAS TAKEN USING COPAN MEDIA/TUBE, CATALOG NUMBER REF 3C047N 3ML LOT # B001899, EXPIRATION DATE 30APR2022. THERE WAS NO ALLEGATION OF HARM. A REVIEW OF THE DATA ASSOCIATED WITH THE PATIENT SAMPLE AND CAN CONFIRM A POSITIVE FLU A RESULT WAS GENERATED WITH CT=35.9 NEAR THE CUTOFF AND LOW AMPLIFICATION CONSISTENT WITH SAMPLES NEAR THE LIMIT OF DETECTION (LOD). THIS RUN SHOWS NO ABNORMALITIES IN THE PCR CURVES. IT IS POSSIBLE THAT THIS RESULT CONTAINS VIRAL MATERIAL NEAR THE LOD OF THE ASSAY. THERE IS NO INDICATION OF AN ANALYZER ISSUE. THE LOD AND THE TYPE OF INFLUENZA VIRAL STRAINS DETECTED DIFFERS SIGNIFICANTLY BETWEEN THE SCFA ASSAY ON THE COBAS® LIAT® SYSTEM AND THE CEPHEID GENEXPERT ASSAYS. AS SUCH, RESULTS WITH ONE ASSAY MAY NOT BE REPRODUCIBLE WITH A DIFFERENT ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627975 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 01123Y

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR