BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® LIAT® SARS-COV-2 & INFLUENZA A/B

    MDR report key: 13663451 · Received March 3, 2022

    Report

    Report Number
    2243471-2022-00273
    Event Type
    Malfunction
    Date Received
    March 3, 2022
    Date of Event
    February 4, 2022
    Report Date
    March 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
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER A REVIEW OF THE CURVES FOR THE ALLEGED SAMPLE, TRUE AMPLIFICATION OF THE SARS-COV-2 CHANNEL CAN BE OBSERVED. A PRODUCT PROBLEM WAS NOT IDENTIFIED. THE DISCREPANCY MAY BE DUE TO THE DIFFERENCES IN SENSITIVITIES AS WELL AS DETECTION TECHNOLOGIES BETWEEN THE LIAT AND THE DIFFERENT TESTS USED TO TEST THE SAMPLE. FACILITY NAME TRUNCATED DUE TO CHARACTER LIMIT: (B)(6) LABORATORIES LTD. (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 TAIWAN 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. THE SAME SAMPLE WAS RETESTED ON DIFFERENT PLATFORMS (LAB-URBO AND CDC) AND YIELDED A NEGATIVE RESULT FOR SARS-COV-2. THE NEGATIVE 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
    1288169 COBAS® LIAT® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 11129U

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown