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: 12223054 · Received July 25, 2021

    Report

    Report Number
    2243471-2021-02712
    Event Type
    Malfunction
    Date Received
    July 25, 2021
    Date of Event
    May 18, 2021
    Report Date
    August 9, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED. THE CUSTOMER COLLECTED NASOPHARYNGEAL SAMPLES USING THE COPAN VTM LOT 3U044N, EXPIRATION 04/30/2022, WHICH IS AN ON-LABEL COLLECTION KIT. OUT OF THE 15 SAMPLES, DATA WAS AVAILABLE FOR 7 OF THEM AND THE POSITIVE SARS RESULT GENERATED ON LIAT WAS CONFIRMED. THE MOST LIKELY CAUSE FOR THE DISCREPANCY OBSERVED IS DUE TO THE SAMPLES HAVING A LOW VIRAL LOAD AND DIFFERENCES IN TESTING PLATFORMS. NOTE THAT SAMPLES NEAR OR BELOW THE LOD OF THE TEST MAY GENERATE WAVERING RESULTS. THE LOD FOR GENEXPERT IS CLAIMED AT 0.0200 PFU/ML. THE PACKAGE INSERT FOR THE COBAS® LIAT SARS-COV-2 & INFLUENZA A/B INDICATES THAT THE LIAT SYSTEM SARS-COV-2 LOD IS 0.012 TCID50/ML (0.0084 PFU/ML)T. THEREFORE, THE LIAT SYSTEM WILL DETECT SARS-COV-2 WHEN THE VIRAL LOAD IS LOW, WHERE THE GENEXPERT REQUIRES A HIGHER VIRAL LOAD IN THE SAMPLE FOR DETECTION. ALSO, THERE ARE DIFFERENCES IN VIRAL STRAINS DETECTED BY EACH ANALYZER. AS SUCH, RESULTS WITH ONE ASSAY MAY NOT BE REPRODUCIBLE WITH A DIFFERENT ASSAY. (B)(4)

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS ON-GOING. A SUPPLEMENTAL REPORT WILL BE FILE UPON 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 FORM THE UNITED STATES ALLEGED DISCREPANT RESULTS WHEN USING THE COBAS® SARS-COV-2 & INFLUENZA A/B ASSAY WHEN COMPARED TO A COMPETITOR EUA. PATIENT SAMPLES WERE COLLECTED USING NASOPHARYNGEAL AND COPAN MEDIA. AS PER THE METHOD SHEET, COLLECT SPECIMEN USING A STERILE FLOCKED SWAB WITH A SYNTHETIC TIP ACCORDING TO APPLICABLE MANUFACTURER INSTRUCTIONS AND/OR STANDARD COLLECTION TECHNIQUE USING 3 ML OF VIRAL TRANSPORT MEDIA OR STERILE 0.9% PHYSIOLOGICAL SALINE. FIFTEEN (15) MDRS WILL BE SUBMITTED, ONE PER PATIENT, AS PER FDA GUIDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119763 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 10322X

    Patients

    Seq Age Sex Outcome Treatment
    1