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: 12022237 · Received June 17, 2021

    Report

    Report Number
    2243471-2021-02004
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 10, 2021
    Report Date
    September 8, 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
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION ON THE REAGENT KIT LOT DID NOT IDENTIFY AND PRODUCT PROBLEM. THESE SAMPLES WERE THROAT SAMPLES, 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. THERE COULD HAVE BEEN CONTAMINATION OF THE SAMPLE AS ONE SAMPLE GENERATED A VERY EARLY CT INDICATING STRONG AMPLIFICATION. A REVIEW OF THE DATA REVEALED LATE CT VALUES FOR THREE SAMPLES, INDICATIVE A LOW TITER SAMPLE NEAR THE LIMIT OF DETECTION (LOD). LOD SAMPLES ARE EXPECTED TO WAIVER BETWEEN POSITIVE AND NEGATIVE UPON REPEAT. ADDITIONALLY, IT IS POSSIBLE THE DISCREPANCY BETWEEN RESULTS IS DUE TO THE DIFFERENCE IN TECHNOLOGIES BETWEEN THE TWO PLATFORMS USED. ADDITIONALLY, DUE TO DIFFERENCES IN ALGORITHMS AND METHOD SENSITIVITIES, RESULTS BETWEEN DIFFERENT ASSAYS MAY VARY.CN-606075.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS ONGOING. SUPPLEMENTAL REPORTS WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. (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 (B)(6) ALLEGED THE GENERATION OF 6 DISCREPANT SARS-COV-2 RESULTS FOR PATIENTS SAMPLES WHEN USING THE COBAS LIAT SARS-COV-2 AND INFLUENZA A/B TEST COMPARED TO THE RETEST RESULTS. THE ALLEGED SAMPLES GENERATED A SARS-COV-2 POSITIVE RESULTS IN THE INITIAL TEST ON THE COBAS LIAT SYSTEM. THESE SAMPLES WERE SENT TO ANOTHER LAB AND RETESTED AFTER 7 DAYS, GENERATED NEGATIVE RESULTS. NEW SAMPLES WERE COLLECTED FROM THE PATIENTS. 5 NEWLY COLLECTED PATIENT SAMPLES FROM THE PATIENTS ORIGINALLY TESTED SARS-COV-2 POSITIVE, GENERATED A NEGATIVE SARS-COV-2 RESULT IN A DIFFERENT LAB WITH AN UNKNOWN TEST. THESE ARE NASAL / THROAT SAMPLES, THE PRODUCTS¿ METHOD SHEETS INDICATES 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. THE INITIAL POSITIVE RESULTS WERE RELEASED. NO HARM WAS ALLEGED. INVESTIGATION IS ONGOING. SIX (6) MDR WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911336 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 01207Z

    Patients

    Seq Age Sex Outcome Treatment
    1