BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13056256 · Received December 21, 2021

    Report

    Report Number
    2243471-2021-03870
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    November 21, 2021
    Report Date
    December 21, 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
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATA WAS PROVIDED AND REVIEWED AND IT WAS OBSERVED THAT RUN (B)(6) PRODUCED A POSITIVE SARS RESULT WITH A CT OF 37.1. THIS CT VALUE INDICATES VERY LOW LEVEL VIRUS PRESENT AND THE CURVE DOES NOT APPEAR TO HAVE ANY ABNORMALITIES. OVERALL, NOTHING WAS SEEN TO INDICATE THE ANALYZER MAY BE PERFORMING SUB-OPTIMALLY. HENCE THE DATA SET ONLY INCLUDED 6 RUNS, INDICATION THAT THE SAMPLE CONTAINED A VIRAL TARGET CONCENTRATION AT THE LIMIT OF DETECTION OF THE ASSAY. THEREFORE, DISCREPANCIES AT THIS LEVEL CAN BE EXPECTED WITH REPEAT TESTING. THE ISSUE IS SAMPLE SPECIFIC AND NO PRODUCT PROBLEM WAS IDENTIFIED. (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 WITH THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC (SCFA) ACID TEST FOR USE ON THE COBAS® LIAT® SYSTEM. THE CUSTOMER REPORTED THAT THE INITIAL TEST GENERATED SARS-COV-2 POSITIVE. THE SAME SAMPLE WAS REPEATED WITH THE GENEXPERT CEPHEID GENERATED NEGATIVE RESULTS FOR ALL 3 TARGETS. THE NEGATIVE RESULTS WERE REPORTED TO THE PATIENT AND OR/ MEDICAL PERSONNEL TREATING THE PATIENT. NO APPARENT HARM OR INJURY OCCURRED IN RELATION TO THE EVENT. THE CUSTOMER COLLECTED A DEEP THROAT SALIVA IN SWEN BRAND VTM SAMPLE, WHICH IS CONSIDERED AN OFF LABEL PRACTICE. THE METHOD SHEET INDICATES THAT ; 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. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER¿S ALLEGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951555 COBAS® LIAT® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 10802Y

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female