BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12006158 · Received June 15, 2021

    Report

    Report Number
    2243471-2021-01923
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 19, 2021
    Report Date
    July 12, 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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE REAGENT KIT LOT DID NOT IDENTIFY ANY PRODUCT ISSUES. REVIEW OF THE RUN DATA SHOWED THE SAMPLE HAD A POSITIVE RESULT FOR THE SARS TARGET WITH A DELAYED CT OF 35.7, FALLING IN THE LIMIT OF DETECTION (LOD) RANGE. THE PCR CURVE IS REPRESENTATIVE OF TRUE AMPLIFICATION. NO ABNORMALITIES ARE OBSERVED IN THE CURVE FOR THIS SAMPLE. IT'S LIKELY THE DISCREPANCY COMES FROM BOTH BEING IN THE LOD RANGE AND THE DIFFERENCES IN ASSAY SENSITIVITY. RELEVANT TEST/LABORATORY DATA WAS UPDATED TO INCLUDE, BOTH THE ORIGINAL SAMPLE AND RECOLLECTED SAMPLE WERE SENT TO THE LAB FOR TESTING WITH THE CEPHEID ASSAY AND BOTH PRODUCED NEGATIVE RESULTS. (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 THE GENERATION OF DISCREPANT RESULTS FOR A PATIENT SAMPLE WHEN USING THE COBAS® SARS-COV-2 & INFLUENZA A/B TEST ON THE COBAS® LIAT® SYSTEM COMPARED TO RETEST RESULTS. THE ALLEGED SAMPLE GENERATED A POSITIVE SARS-COV-2 RESULT IN THE INITIAL TESTING ON (B)(6) 2021. A NEW SAMPLE WAS COLLECTED ON (B)(6) 2021 AND TESTED ON THE CEPHEID SYSTEM. THE RESULT WAS NEGATIVE. BOTH THE INITIAL AND RETEST RESULTS WERE REPORTED. NO HARM WAS ALLEGED. THE SAMPLE WAS A NASOPHARYNGEAL SAMPLE COLLECTED IN AERO MED VTM. 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. AN INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902119 COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 10304X

    Patients

    Seq Age Sex Outcome Treatment
    1