BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 & INFLUENZA A/B

    MDR report key: 16152765 · Received January 12, 2023

    Report

    Report Number
    2243471-2023-00039
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    December 19, 2022
    Report Date
    January 12, 2023
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QLT
    PMA / PMN Number
    EUA202635
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DATA WAS PROVIDED FOR REVIEW AND ANALYSIS. WITHOUT DATA (INCLUDING LOT INFORMATION), SAMPLE SPECIFICS, OR PATIENT INFORMATION A COMPLETE ANALYSIS COULD NOT BE COMPLETED. ALTHOUGH THE ROOT CAUSE CANNOT BE CONFIRMED DUE TO A LACK OF INFORMATION, IT IS LIKELY THAT THE DISCREPANCY IS RELATED TO THE DIFFERENCES IN TECHNOLOGY. IT CAN BE CONCLUDED BASED ON THE FACT THAT THE POSITIVE RESULT WAS REPEATED 2X WITH THE SAME SAMPLE THAT A PRODUCT PROBLEM IS UNLIKELY. THE REASON FOR THE DISCREPANT RESULTS IS SAMPLE SPECIFIC, EITHER DUE TO DIFFERENCES IN TECHNOLOGY INCLUDING THE SENSITIVITY OF THE ASSAYS, OR THE DIFFERENCE IN SAMPLE TYPE/COLLECTION AS A NEW SAMPLE WAS COLLECTED AND TESTED AT THE UNSPECIFIED HOSPITAL. THE SARS-COV-2 DETECTION KIT ON SMART GENE SYSTEM, MANUFACTURER MIZUO MEDY CO. LTD. IS A RAPID TEST AND MAY NOT BE AS SENSITIVE. THE CUSTOMER ISSUE HAS BEEN ALLEGED ON THE COBAS SARS-COV-2 & INFLUENZA A/B QUALITATIVE ASSAY FOR USE ON THE COBAS 5800/6800/8800 SYSTEMS CE-IVD, CATALOG NUMBER 09446125190 AND UDI (B)(4) WHICH IS NOT YET AVAILABLE IN THE US. THE SIMILAR ASSAY CURRENTLY AVAILABLE IN THE US UNDER EMERGENCY USE AUTHORIZATION IS THE COBAS SARS-COV-2 & INFLUENZA A/B QUALITATIVE ASSAY FOR USE ON THE COBAS 6800/8800 SYSTEMS (EUA202635, PRODUCT CODE: QLT). THE PRODUCT CATALOG NUMBER FOR THE TEST (384T) IS 09233474190 AND THE UDI IS (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 JAPAN ALLEGED DISCREPANT RESULTS WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS® 5800/6800/8800 SYSTEMS. 5 POOLED SAMPLES WERE RUN ON COBAS 8800 AND GENERATED A POSITIVE RESULT FOR SARS-COV-2. THE 5 POOLED SAMPLES WERE INDIVIDUALLY TESTED ON THE COBAS 6800 AND 1 SAMPLE GENERATED A POSITIVE RESULT FOR SARS-COV-2. THE FOLLOWING DAY, A NEW SAMPLE WAS COLLECTED FROM THE PATIENT THAT GENERATED THE POSITIVE RESULT AND WAS RUN A COMPETITOR PLATFORM (SARS-COV-2 DETECTION KIT ON SMART GENE SYSTEM, MANUFACTURER MIZUO MEDY CO. LTD. ) WHICH YIELDED A NEGATIVE RESULT FOR SARS-COV-2. THE RESULTS WERE RELEASED. 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
    1465063 COBAS® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown