BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 & INFLUENZA A/B

    MDR report key: 15418120 · Received September 14, 2022

    Report

    Report Number
    2243471-2022-00786
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Date of Event
    August 20, 2022
    Report Date
    September 14, 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

    A REVIEW OF THE PROVIDED DATA INDICATED THAT THE ALLEGED SAMPLE IS A LOW TITER SAMPLE. THIS WOULD EXPLAIN WHY WAVERING RESULTS WERE GENERATED WHEN THE SAMPLE WAS REPEATED. THIS IS A SAMPLE-SPECIFIC ISSUE AND THE REAGENT IS PERFORMING AS INTENDED. THE OBSERVED DISCREPANCY IS MOST LIKELY DUE TO THE SAMPLE BEING A WEAK POSITIVE FOR THE SARS-COV-2 TARGET THAT IS AT/NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY. VERY LOW VIRAL LOAD SPECIMENS THAT ARE NEAR THE ASSAY LOD MAY NOT GENERATE CONSISTENT RESULTS UPON REPEAT TESTING ACCORDING TO EXPECTED STATISTICAL VARIANCES IN DETECTION. A RESULT DISCREPANCY MAY BE EXPECTED BETWEEN ASSAYS DUE TO POTENTIAL DIFFERENCES IN THE TESTS¿ LIMITS OF DETECTION (LOD) AND INTENDED USE. OF NOTE, THE CUSTOMER IS COLLECTING THROAT SALIVA TESTS IN LONGSEE VIRAL TRANSPORT MEDIA, 3ML WHICH IS OFF-LABEL.

    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 B) WHEN TESTED ON COBAS LIAT. THE SAME SAMPLE WAS RETESTED ON A DIFFERENT PLATFORM (GENEXPERT) WHICH YIELDED A NEGATIVE RESULT. THE NEGATIVE RESULT WAS 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
    2785119 COBAS® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 20207L

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male