BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12562561 · Received October 1, 2021

    Report

    Report Number
    2243471-2021-03436
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Date of Event
    September 2, 2021
    Report Date
    December 22, 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
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DATA CONFIRMED THAT SAMPLE RUN #1785 AS POSITIVE FOR SARS-COV-2 WITH A CT VALUE OF 36. AN INDICATIVE OF A SAMPLE THAT IS NEAR, AT, OR PAST THE LIMIT OF DETECTION OF THE ASSAY (LOD), WHICH CAN CAUSE THE SAMPLE TO WAIVER BETWEEN POSITIVE AND NEGATIVE, OR OTHER SAMPLE SPECIFIC FACTORS. ADDITIONALLY WE CANNOT RULED OUT SPECIFIC FACTORS SUCH AS; THE DIFFERENCES IN THE SENSITIVITY OF THE TWO TESTS (LIAT TEST AND THE SEEGENE). THE LIAT ASSAY HAS A LOD OF 12 COPIES/ML, OR 0.0084 PFU/ML. THE SEEGENE ALLPLEX 2019-NCOV ASSAY HAS A LOD OF 4167 CP/ML2, 0.0200 PFU/ML. THE LIAT ASSAY IS MORE THAN 2 TIMES SENSITIVE THAN THE GENEXPERT ASSAY. CN-634448.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED UPON THE COMPLETION OF THE INVESTIGATION. (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 (B)(6) ALLEGED A DISCREPANT RESULT WHEN USING THE COBAS® SARS-COV-2 AND INFLUENZA A/B NUCLEIC ACID TEST FOR USE ON THE COBAS® LIAT® SYSTEM WHEN COMPARED TO THE RESULT GENERATED BY SEEGENE® ALLPLEX SARS-COV-2 ASSAY. ACCORDING TO THE CUSTOMER THE INITIAL PATIENT SAMPLE WAS TESTED USING THE COBAS® LIAT® SYSTEM AND GENERATED SARS-COV-2. A SECOND SWAB WAS RE-COLLECTED REPEATED USING THE SEEGENE® ALLPLEX SARS-COV-2 ASSAY, THE RESULT WAS SARS-COV-2 NEGATIVE. ALTHOUGH REQUESTED, IT IS STILL UNKNOWN WHETHER ANY OF THE RESULTS WERE REPORTED TO THE PATIENT. TO DATE NO ALLEGATION OF HARM OR INJURY IS ALLEGED. INVESTIGATION IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463738 COBAS® LIAT® SARS-COV-2 & INFLUENZA A/B REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 10601Y

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male