BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12841178 · Received November 18, 2021

    Report

    Report Number
    2243471-2021-03739
    Event Type
    Malfunction
    Date Received
    November 18, 2021
    Date of Event
    October 15, 2021
    Report Date
    November 18, 2021
    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
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE SAMPLE DATA SHOWED THAT, RUN 4980 HAS VERY WEAK AMPLIFICATION AND A LATE CT, WHICH IS CONSISTENT WITH A LOW TITER SAMPLE. LOW TITER SAMPLES, THAT ARE NEAR THE LIMIT OF DETECTION, MAY NOT GENERATE CONSISTENT RESULTS UPON REPEAT TESTING. ADDITIONALLY, DUE TO INHERENT DIFFERENCES IN TECHNOLOGIES, RESULTS BETWEEN DIFFERENT ASSAYS MAY VARY. NO PRODUCT PROBLEM RELATED TO THE CUSTOMER ALLEGATION WAS OBSERVED. (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 A DISCREPANT RESULT GENERATED WHILE USING A COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC (SCFA) ACID TEST FOR USE ON THE COBAS® LIAT SYSTEM WHEN COMPARED TO THE RESULT GENERATED WITH GENEXPERT® CEPHEID. THERE IS NO INDICATION OF ANY PATIENT HARM OR INJURY. THE CUSTOMER REPORTED THAT ON (B)(6) 2021, THE PATIENT SAMPLE WAS INITIALLY TESTED WITH THE COBAS® LIAT® (B)(4) (RUN 4980) USING THE REAGENT LOT 10802Z. THE RESULTS WERE INFLUENZA A POSITIVE, INFLUENZA B AND SARS-COV-2 NEGATIVE. THE SAME SAMPLE WAS RETESTED ON A DIFFERENT PLATFORM AND GENERATED NEGATIVE RESULTS FOR ALL 3 TARGETS. THE NEGATIVE RESULTS WERE REPORTED TO THE PATIENT AND/ OR MEDICAL PERSONNEL TREATING THE PATIENT. THE SAMPLE WAS COLLECTED USING A NASOPHARYNGEAL SAMPLE AND PCR MEDIA TUBES (CAT 08042968001) WHICH IS NOT CONSIDERED A RECOMMENDED PRACTICE. THE 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¿ REMEASURED 3 ML 0.9% PHYSIOLOGICAL SALINE SOLUTION. TESTING OF OTHER SAMPLE OR MEDIA TYPES MAY LEAD TO INACCURATE RESULT. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER¿S ALLEGATION. REVIEW OF THE SAMPLE DATA SHOWED THAT, RUN 4980 HAS VERY WEAK AMPLIFICATION AND A LATE CT VALUE, WHICH IS CONSISTENT WITH A LOW TITER SAMPLE. LOW TITER SAMPLES, THAT ARE NEAR THE LIMIT OF DETECTION, MAY NOT GENERATE CONSISTENT RESULTS UPON REPEAT TESTING. ADDITIONALLY, DUE TO INHERENT DIFFERENCES IN TECHNOLOGIES, RESULTS BETWEEN DIFFERENT ASSAYS MAY VARY. NO PRODUCT PROBLEM RELATED TO THE CUSTOMER ALLEGATION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737372 COBAS® LIAT® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 10802Z

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown