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: 12425852 · Received September 3, 2021

    Report

    Report Number
    2243471-2021-03192
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 6, 2021
    Report Date
    September 3, 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
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATASET PROVIDED HAS BEEN REVIEWED AND NO INDICATION FOR A POTENTIAL FALSE-POSITIVE RESULT COULD BE FOUND. FURTHERMORE NO HARDWARE ISSUE COULD BE FOUND IN THE DATA. BASED ON THIS INVESTIGATION THIS ANALYZER MAY REMAIN IN OPERATION. (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 SPAIN ALLEGED A DISCREPANT RESULT WITH THE COBAS® LIAT® SARS-COV-2/FLU TEST (SCFA) FOR USE ON THE LIAT SYSTEM. NO HARM WAS INDICATED. ACCORDING TO THE CUSTOMER, THE INITIAL SAMPLE WAS TESTED WITH THE COBAS® LIAT® SYSTEM AND GENERATED A SARS-COV-2 POSITIVE RESULT. THE SAME SAMPLE WAS RETESTED USING A COMPETITOR PLATFORM AND THE RESULT WAS NEGATIVE. ALTHOUGH REQUESTED, IT IS STILL UNKNOWN WHICH RESULTS WERE REPORTED TO THE PATIENT AND/OR MEDICAL PERSONNEL. THE CUSTOMER COLLECTED NASOPHARYNGEAL SAMPLES USING MANUFACTURER GENESIS. VOL: 3ML, WHICH IS NOT CONSIDERED A RECOMMENDED 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 WHICH DID NOT IDENTIFY ANY PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320796 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 10419Z

    Patients

    Seq Age Sex Outcome Treatment
    1