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: 11698364 · Received April 20, 2021

    Report

    Report Number
    2243471-2021-00874
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 22, 2021
    Report Date
    April 20, 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 ON THE REAGENT KIT LOT AND NO PRODUCT PROBLEM WAS IDENTIFIED. BASED ON THE INFORMATION AND DATA PROVIDED AND THE INVESTIGATION PERFORMED THERE IS NO INDICATION THE PRODUCT IS NOT 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. THE CUSTOMER ALLEGED DISCREPANT RESULTS USING THE COBAS® SARS-COV-2 ASSAY. A CUSTOMER FROM THE UNITED STATES ALLEGED DISCREPANT RESULTS FOR A PATIENT USING THE COBAS® SARS-COV-2 & INFLUENZA A/B ASSAY GENERATED ON THE COBAS LIAT SYSTEM (S/N (B)(4)). ON (B)(6) 2021 THE CUSTOMER REPORTED THAT THEY INITIALLY RAN THE PATIENT SAMPLE ON THE COBAS LIAT SYSTEM (S/N (B)(4)) WHICH GENERATED A FALSE POSITIVE RESULT. THE CUSTOMER REPORTED THAT THE INITIAL PATIENT SAMPLE RESULTS GENERATED WERE SARS-COV-2 POSITIVE, INFLUENZA A NEGATIVE, INFLUENZA B NEGATIVE RESULTS. THE SAME PATIENT SAMPLE WAS RETESTED ON A NON-ROCHE PLATFORM, THE CEPHEID GENEXPERT THAT GENERATED SARS-COV-2 NEGATIVE, INFLUENZA A NEGATIVE, INFLUENZA B NEGATIVE RESULTS. PATIENT SAMPLE WAS COLLECTED USING NASOPHARYNGEAL SWAB AND UTM MEDIA WITH A FLOCKED SWAB. THIS IS NOT A RECOMMENDED PRACTICE FOR SAMPLE COLLECTION. 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. THE POSITIVE RESULTS WERE REPORTED TO THE PATIENT, BUT THE PATIENT WAS NOT TREATED. THE CUSTOMER CONFIRMED THERE WAS NO ALLEGATION OF HARM TO THE PATIENT. AN INVESTIGATION WAS PERFORMED WHICH DID NOT IDENTIFY ANY PRODUCT ISSUE. THE CUSTOMER PROVIDED A PROBLEM REPORT FROM THE ASSOCIATED ANALYZER AND THE DATA WAS REVIEWED. THE ALLEGED DISCREPANT RESULT WAS IDENTIFIED AND CONFIRMED ON THE COBAS LIAT SYSTEM ANALYZER (B)(4). THE OBSERVED DISCREPANCY WAS MOST LIKELY DUE TO THE PATIENT SAMPLE BEING A WEAK POSITIVE FOR SARS-COV-2 TARGET THAT IS AT/NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY. 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. DISCREPANCY MAY BE OBSERVED DUE TO THE DIFFERENCES BETWEEN TECHNOLOGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590455 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 00831Z

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR