BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 & INFLUENZA A/B

    MDR report key: 14017857 · Received April 5, 2022

    Report

    Report Number
    2243471-2022-00365
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    March 8, 2022
    Report Date
    April 5, 2022
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QLT
    PMA / PMN Number
    EUA201779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGHOUT THE DATA ANALYSIS, A SYSTEMATIC ISSUE WAS NOT OBSERVED AND A PRODUCT PROBLEM WAS NOT FOUND. THE MOST LIKELY CAUSE FOR THE DISCREPANCY OBSERVED IS DUE TO SAMPLE HANDLING OR THE OFF-LABEL COLLECTION KIT. THE COLLECTION KIT, GUANGDONG LONGSEE BIOMEDICAL CO., LTD SAMPLE PRESERVATION SOLUTIONS (INACTIVATED), IS OFF-LABEL. THE SCFA ASSAY METHOD SHEET RECOMMENDS TO COLLECT SPECIMEN USING A STERILE FLOCKED SWAB WITH A SYNTHETIC TIP USING 3 ML OF VIRAL TRANSPORT MEDIA ACCORDING TO APPLICABLE MANUFACTURER INSTRUCTIONS AND STANDARD COLLECTION TECHNIQUE. VALIDATED COLLECTION MEDIA KITS FOR EACH SPECIMEN TYPE CAN BE FOUND IN THE METHOD SHEET. COLLECTION KITS THAT ARE NOT RECOMMENDED IN THE METHOD SHEET COULD HAVE A DIFFERENT CHEMICAL COMPOSITION AND AFFECT THE PERFORMANCE OF THE ASSAY. IN ADDITION, THE LOD AND THE TYPE OF SARS-COV-2 GENES DETECTED DIFFERS SIGNIFICANTLY BETWEEN THE COBAS® SARS-COV-2 & INFLUENZA A/B ASSAY ON THE COBAS® LIAT® SYSTEM AND THE CEPHEID GENEXPERT ASSAYS. AS SUCH, RESULTS WITH ONE ASSAY MAY NOT BE REPRODUCIBLE WITH A DIFFERENT ASSAY. (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 HONG KONG ALLEGED A DISCREPANT RESULT FOR A SINGLE PATIENT WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. THE ALLEGED SAMPLE INITIALLY GENERATED A POSITIVE RESULT FOR SARS-COV-2, NEGATIVE FOR INFLUENZA A AND INFLUENZA B. THE SAME SAMPLE WAS RETESTED ON A SAME COBAS LIAT AND GENEXPERT AND RESULTS WERE NEGATIVE. THE NEGATIVE RESULTS WERE REPORTED. NO HARM WAS ALLEGED. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER ISSUE. PER FDA¿S EUA GUIDANCE, 1 MDR WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813004 COBAS® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 20117L

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male