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: 12097556 · Received June 30, 2021

    Report

    Report Number
    2243471-2021-02242
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    May 31, 2021
    Report Date
    June 30, 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

    THE INVESTIGATION PERFORMED ON THE CUSTOMER PROVIDED DATA INDICATED THAT THE ALLEGED SAMPLE GENERATED A POSITIVE RESULT CT OF 35.1 FOR THE SARS TARGET. IN CONCLUSION, THE OBSERVED DISCREPANCY IS MOST LIKELY DUE TO THE SAMPLE BEING NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY AND THE DIFFERENCES IN ASSAY SENSITIVITY THE CUSTOMER'S ALLEGATION IS SUBSTANTIATED. (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 THE US ALLEGED A POSITIVE RESULT GENERATED ON A PATIENT SAMPLE WITH THE COBAS® LIAT® SARS-COV-2/FLU TEST ON THE COBAS® LIAT® SYSTEM WHEN COMPARED TO THE RESULTS GENERATED WITH OTHER PLATFORMS. ACCORDING TO THE CUSTOMER THE TESTS FOR THIS PATIENT WERE PERFORMED FOUR TIMES WITH MULTIPLE ASSAYS AND 3 SAMPLE COLLECTIONS: ¿ RUN 1 - 5/29 - GENEXPERT CEPHEID GENERATED NEGATIVE FOR SARS-COV2, NEGATIVE FOR FLU A, NEGATIVE FOR FLU B (SAMPLE 1 USED) ¿ RUN 2 - 5/30 - COBAS® LIAT® SYSTEM SN (B)(4) GENERATED POSITIVE FOR SARS-COV2, NEGATIVE FOR FLU A, NEGATIVE FOR FLU B (SAMPLE 2 USED) ¿ RUN 3 - 5/31 - PANTHER - NEGATIVE FOR SARS-COV2, NEGATIVE FOR FLU A, NEGATIVE FOR FLU B (SAMPLE 3 USED) ¿ RUN 4 - 5/31 - GENEXPERT GENERATED NEGATIVE FOR SARS-COV2, NEGATIVE FOR FLU A, NEGATIVE FOR FLU B (SAMPLE 2 USED) BOTH THE INITIAL (POSITIVE) AND THE NEGATIVE RESULTS WERE REPORTED TO CLINICAL PERSONNEL AND THE PATIENT. THE ALLEGED SAMPLE WAS NASOPHARYNGEAL COLLECTED IN AN UNKNOWN MEDIA. THE METHOD SHEET INDICATES THE TEST IS INTENDED TO BE USED FOR THE DETECTION OF SARS-COV-2, INFLUENZA A AND INFLUENZA B RNA IN NASAL AND NASOPHARYNGEAL SWAB SAMPLES COLLECTED IN A COPAN UTM-RT SYSTEM (UTM-RT) OR BD¿ UNIVERSAL VIRAL TRANSPORT SYSTEM (UVT) OR THERMO FISHER¿ SCIENTIFIC REMEL¿ MEDIA, OR THOMAS SCIENTIFIC MANTACC¿ PREMEASURED 3 ML 0.9% PHYSIOLOGICAL SALINE SOLUTION. TESTING OF OTHER SAMPLE OR MEDIA TYPES MAY LEAD TO INACCURATE RESULTS.HYBRID UTM 3ML (SIMILAR TO COPAN) AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987412 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 01207U

    Patients

    Seq Age Sex Outcome Treatment
    1