BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 & INFLUENZA A/B

    MDR report key: 14596504 · Received June 3, 2022

    Report

    Report Number
    2243471-2022-00528
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    May 16, 2022
    Report Date
    June 3, 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
    US
    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 THE SAMPLES HAVING A LOW VIRAL LOAD, EITHER FROM A PATIENT WITH A LOW TITER OR FROM LAB CROSS-CONTAMINATION. NOTE THAT SAMPLES NEAR OR BELOW THE LOD OF THE TEST MAY GENERATE WAVERING RESULTS ON REPEAT TESTING. (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 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 WAS INITIALLY TESTED ON THE COBAS® LIAT® SYSTEM (S/N 10855) GENERATED POSITIVE RESULTS FOR SARS-COV-2 AND INFLUENZA A AND A NEGATIVE RESULT FOR INFLUENZA B. THE SAME SAMPLE WAS RETESTED 20 MINUTES LATER ON A DIFFERENT COBAS® LIAT® SYSTEM (S/N 20156) WHICH YIELDED A POSITIVE RESULT FOR INFLUENZA A AND NEGATIVE RESULTS FOR SARS-COV-2 AND INFLUENZA B. INFLUENZA A POSITIVE 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
    1587744 COBAS® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 20228T

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown