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: 11823614 · Received May 13, 2021

    Report

    Report Number
    2243471-2021-01272
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 15, 2021
    Report Date
    May 14, 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
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM POLAND ALLEGED A DISCREPANT SARS-COV-2 RESULT FOR A SINGLE PATIENT WHILE TESTING WITH THE COBAS® SARS-COV-2 & INFLUENZA A/B TEST ON THE LIAT ANALYZER. NO HARM WAS ALLEGED. AN INVESTIGATION INDICATED THE SAMPLE WAS NEAR THE LIMIT OF DETECTION AND THE PRODUCT IS FUNCTIONING AS INTENDED. (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 FROM POLAND ALLEGED A DISCREPANT RESULT FOR A SINGLE PATIENT WHILE TESTING WITH THE COBAS® SARS-COV-2 & INFLUENZA A/B TEST ON THE LIAT ANALYZER (SN:(B)(4)). THE PATIENT SAMPLE INITIALLY GENERATED A SARS-COV-2 POSITIVE RESULT BUT WAS NEGATIVE WHEN REPEATED ON ANOTHER ANALYZER. THE NEGATIVE REPEAT RESULT WAS RELEASED AND NO HARM WAS ALLEGED. AN INVESTIGATION WAS CONDUCTED WHICH DID NOT IDENTIFY ANY PRODUCT PROBLEM. REVIEW OF THE RUN DATA REVEALED DELAYED AMPLIFICATION AND A LATE CT VALUE INDICATIVE OF A SAMPLE NEAR OR BELOW THE LIMIT OF DETECTION (LOD). 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. THE PRODUCT IS WORKING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714953 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 01207Z

    Patients

    Seq Age Sex Outcome Treatment
    1