BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13360826 · Received January 26, 2022

    Report

    Report Number
    2243471-2022-00136
    Event Type
    Malfunction
    Date Received
    January 26, 2022
    Date of Event
    January 2, 2022
    Report Date
    January 26, 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
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATA WAS PROVIDED AND REVIEWED AND CONFIRMED THAT ALL 3 SAMPLE RUNS GENERATED POSITIVE RESULTS FOR SARS-COV-2 AND ARE NEAR THE LOD OF THE ASSAY (THEY ARE FAIRLY LATE CTS). NO ABNORMALITIES WERE OBSERVED IN THE DATA. IT IS POSSIBLE THAT THE DISCREPANCY IS DUE TO THE DIFFERING SENSITIVITY BETWEEN THE ASSAYS. HOWEVER, SAMPLES IN THE LOD RANGE CAN WAVER IN RESULT UPON REPEAT TESTING WHICH EXPLAINS THE DISCREPANCY. NO PRODUCT PROBLEM SEEN. (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 ALLEGED DISCREPANT RESULTS WHEN USING THE COBAS® SARS-COV-2 & INFLUENZA A/B TEST (SCFA) ASSAY FOR USE WITH THE COBAS® SARS-COV-2 & INFLUENZA A/B TEST. THE CUSTOMER REPORTED THAT THE INITIAL 3 SAMPLES TESTED WITH THE COBAS® LIAT® GENERATED SARS-COV-2 POSITIVE. UPON A RETEST WITH THE ALLPLEX¿ SEEGENE SARS-COV-2/FLU A/FLU B/RSV ASSAY. THE CUSTOMER COLLECTED THE SAMPLES USING SUNTRINE SWABS WITH FLOCKED TIP (MODEL 905101) IN GREINER VACUETTE TUBE MET 3 ML VST REF 456161, WHICH IS NOT RECOMMENDED PER THE IFU. THE PRODUCT¿S METHOD SHEET STATES: THIS TEST IS INTENDED TO BE USED FOR THE DETECTION OF SARS-COV-2, INFLUENZA A AND INFLUENZA B RNA IN NASAL AND NASOPHARYNGEAL SWAB SAMPLES COLLECTED IN A COPAN UTM-RT SYSTEM (UTM-RT) OR BD¿ UNIVERSAL VIRAL TRANSPORT SYSTEM (UVT) OR THERMO FISHER¿ SCIENTIFIC REMEL¿ MEDIA, OR THOMAS SCIENTIFIC MANTACC¿ PREMEASURED 3 ML 0.9% PHYSIOLOGICAL SALINE SOLUTION. TESTING OF OTHER SAMPLE OR MEDIA TYPES MAY LEAD TO INACCURATE RESULTS. ALTHOUGH REQUESTED IT IS UNKNOWN WHETHER THE POSITIVE RESULTS WERE REPORTED. NO APPARENT HARM OR INJURY OCCURRED IN RELATION TO THE EVENT. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER¿S ALLEGATION. PER THE FDA GUIDANCE THREE (3) MDRS WILL BE FILED ONE PER RUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178626 COBAS® LIAT® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 10927U

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown