BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS LIAT SARS-COV-2 & INFLUENZA A/B FOR USE ON THE COBAS LIAT ANALYZER SYSTEM

    MDR report key: 12426147 · Received September 3, 2021

    Report

    Report Number
    2243471-2021-03194
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    July 27, 2021
    Report Date
    October 6, 2021
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QJR
    PMA / PMN Number
    EUA201779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM EVALUATION SHOWED BOTH SAMPLES TO BE TRUE POSITIVES WITH LOW TITERS. FURTHER INVESTIGATION OF THE REAGENT DID NOT FIND ANY PRODUCT ISSUES. (B)(4).

    Additional Manufacturer Narrative · 0

    (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 WITH THE COBAS® LIAT® SARS-COV-2/FLU TEST (SCFA) FOR USE ON THE COBAS® LIAT® SYSTEM. THE TWO INITIAL PATIENT TESTS RUN ON THE COBAS® LIAT® (B)(4) WERE SARS-COV2 POSITIVE. 3 FOLLOW UP SWABS WERE RE-COLLECTED FOR PATIENT ONE WHILE 2 FOLLOW SWABS WERE RE-COLLECTED FOR PATIENT TWO. THE NEW RE-COLLECTED SWABS FOR PATIENT ONE ALONG WITH THE SAME INITIAL SAMPLE AND THE RE-COLLECTED SWABS FOR PATIENT 2 WERE REPEATED WITH THE GENEXPERT CEPHEID AND THE RESULTS WERE NEGATIVE. ONLY ONE OF THE INITIAL RESULTS WAS REPORTED. NO HARM IS ALLEGED TO DATE. THE CUSTOMER COLLECTED NASOPHARYNGEAL SAMPLES USING NOBLE BIOSCIENCES COLLECTION TUBE WITH CLINICAL VIRUS TRANSPORT MEDIUM (CTM) REF UTNFS-3B-2, WHICH IS AN OFF-LABEL COLLECTION KIT. 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. PER THE FDA GUIDANCE TWO (2) MDRS WILL BE FILED, ONE (1) PER EACH BATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320435 COBAS LIAT SARS-COV-2 & INFLUENZA A/B FOR USE ON THE COBAS LIAT ANALYZER SYSTEM REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 10315Z

    Patients

    Seq Age Sex Outcome Treatment
    1