BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 & INFLUENZA A/B

    MDR report key: 14187761 · Received April 22, 2022

    Report

    Report Number
    2243471-2022-00431
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    March 18, 2022
    Report Date
    May 31, 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

    AN INVESTIGATION IS IN PROGRESS TO INVESTIGATE THE CUSTOMER ISSUE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT TO PROVIDE THE CASE CONCLUSION FOR 2243471-2022-00431. DATA FROM THE SD CARD EXTRACTED FROM THE LIAT SN (B)(6) WAS PROVIDED. DUE TO THE DATA BEING EXTRACTED FROM THE SD CARD, THE SAMPLE IDS WERE NOT PROVIDED, AND THEREFORE, THE ALLEGED RUNS COULD NOT BE IDENTIFIED. A HOLISTIC REVIEW OF THE DATASET WAS PERFORMED WHERE NO PRODUCT PROBLEM WAS IDENTIFIED. NOTE THAT EACH OF THE POSITIVE RUNS, EXCLUDING THE ONE PERFORMED ON THE BD MAX, GENERATED DELAYED CT VALUES INDICATING A LOW VIRAL PRESENCE IN THE SAMPLE. SAMPLES NEAR THE LOD MAY GENERATE WAVERING RESULTS UPON RETEST. IN REGARDS TO THE SAMPLE TESTED ON THE BD MAX, IT IS POSSIBLE THE DISCREPANCY OCCURRED DUE TO DIFFERENCES IN DETECTION TECHNOLOGIES BETWEEN THE LIAT AND THE BD MAX. NO PRODUCT PROBLEM RELATED TO THE CUSTOMER ALLEGATION WAS IDENTIFIED. ----------- CN- (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 DISCREPANT RESULTS FOR THREE PATIENT SAMPLES WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. AS PART OF VALIDATION, THE CUSTOMER TESTED 3 KNOWN SARS-COV-2 POSITIVE SAMPLES. SAMPLE 1 INITIALLY GENERATED A POSITIVE RESULT FOR SARS-COV-2 ON TWO SEPARATE COBAS LIAT ANALYZERS. THE SAMPLE WAS TESTED A THIRD TIME ON A THIRD COBAS LIAT ANALYZER (S/N 12426) AND GENERATED A NEGATIVE RESULT FOR SARS-COV-2. SAMPLE 2 INITIALLY GENERATED A NEGATIVE RESULT FOR SARS-COV-2 ON COBAS LIAT ANALYZER (S/N 12426). THE SAMPLE WAS RETESTED A DIFFERENT COBAS LIAT ANALYZER (S/N (B)(4) AND GENERATED A POSITIVE RESULT FOR SARS-COV-2. SAMPLE 3 INITIALLY GENERATED A POSITIVE RESULT FOR SARS-COV-2 ON A DIFFERENT PLATFORM (BD MAX). THE SAMPLE WAS RETESTED ON A COBAS LIAT ANALYZER (S/N (B)(4) AND GENERATED A NEGATIVE RESULT FOR SARS-COV-2. NO HARM WAS ALLEGED. AN INVESTIGATION IS ONGOING TO EVALUATE THE CUSTOMER ISSUE. PER FDA¿S EUA GUIDANCE, 3 MDRS WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742585 COBAS® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown