BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® LIAT® SARS-COV-2 & INFLUENZA A/B

    MDR report key: 13088387 · Received December 27, 2021

    Report

    Report Number
    2243471-2021-03918
    Event Type
    Malfunction
    Date Received
    December 27, 2021
    Date of Event
    December 7, 2021
    Report Date
    December 27, 2021
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QLT
    PMA / PMN Number
    EUA201779
    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

    LIAT RESULTS CORRELATE AND REVIEW OF PCR CURVES SHOW NO INDICATION OF FALSE RESULTS. THE DIFFERENCES IN TESTING TECHNOLOGIES COULD EXPLAIN THE SAMPLE DISCREPANCIES. THE LOD DIFFERS SIGNIFICANTLY BETWEEN THE SARS-COV-2 & INFLUENZA A/B (SCFA) TEST ON THE COBAS® LIAT SYSTEM AND THE CEPHEID GENEXPERT WHICH COULD EXPLAIN THE SAMPLE DISCREPANCIES. THE LOD FOR GENEXPERT IS CLAIMED AT 0.0200 PFU/ML. THE SCFA PACKAGE INSERT INDICATES THAT THE LIAT SYSTEM SARS-COV-2 LOD IS 0.012 TCID50/ML (0.0084 PFU/ML) WHICH INDICATES BEING OVER TWICE AS SENSITIVE AS THE GENEXPERT. THEREFORE, THE LIAT SYSTEM WILL DETECT SARS-COV-2 WHEN THE VIRAL LOAD IS LOWER THEN WHAT IS DETECTABLE BY THE GENEXPERT. IN ADDITION TO THE LOD DIFFERENCES, THE TYPE OF INFLUENZA VIRAL STRAINS DETECTED DIFFERS SIGNIFICANTLY BETWEEN THE SCFA (ORF1A/B ALONG WITH THE N GENE) AND THE CEPHEID (N2 TARGET AND E TARGET) 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 ALLEGED A DISCREPANT RESULT FOR A SINGLE PATIENT WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. THE FIRST SAMPLE WAS RUN ON LIAT S/N (B)(4) AND GENERATED INITIAL RESULTS OF POSITIVE SARS-COV-2, POSITIVE INFLUENZA A AND NEGATIVE INFLUENZA B. THIS ORIGINAL SAMPLE, STORED AT 2-8C, WAS RETESTED THE FOLLOWING DAY WITH THE CEPHEID AND RESULTED NEGATIVE SARS-COV-2, POSITIVE INFLUENZA A AND NEGATIVE INFLUENZA B. THE NEXT DAY A RECOLLECTED SAMPLE FROM THE SAME PATIENT WAS RAN ON LIAT S/N (B)(4) AND RESULTED POSITIVE SARS-COV-2, POSITIVE INFLUENZA A AND NEGATIVE INFLUENZA B. THIS SAMPLE WAS RERAN THE SAME DAY ON THE CEPHEID AS NEGATIVE SARS-COV-2, POSITIVE INFLUENZA A, NEGATIVE INFLUENZA B. THE INFLUENZA A POSITIVE RESULTS WERE REPORTED. NO HARM IS ALLEGED CUSTOMER COLLECTS NASOPHARYNGEAL SAMPLES USING BD UTM CATALOG NUMBER 220531, WHICH IS AN ON-LABEL COLLECTION. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER¿S ALLEGATION. PER THE FDA GUIDANCE TWO (2) MDRS WILL BE FILED ONE PER RUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987262 COBAS® LIAT® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 11011Z

    Patients

    Seq Age Sex Outcome Treatment
    1 24 Female