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: 11996739 · Received June 14, 2021

    Report

    Report Number
    2243471-2021-01887
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 16, 2021
    Report Date
    July 24, 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
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE FILED UPON THE COMPLETION OF THE INVESTIGATION. FULL FACILITY NAME: (B)(6). (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION WAS PERFORMED, REVIEWED OF THE RAW DATA CONFIRMED THE ANALYZER IS WORKING AS EXPECTED AND NO SYSTEM ISSUE RELATED TO THE CUSTOMER ALLEGATION WAS IDENTIFIED. ALTHOUGH UNKNOWN, THESE COULD BE LOD SAMPLES EXPLAINING THE DISCREPANCY. (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED LOT NUMBER AND UPDATED EXPIRATION DATE FOR THIS LOT. ONE OF THE SAMPLES USED A DIFFERENT LOT OF REAGENT. (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 DISCREPANT RESULTS GENERATED FOR 3 PATIENT SAMPLES TESTED ON THE COBAS® LIAT ANALYZER WHEN COMPARED TO WITH THE COBAS® 6800 ANALYZER. THREE SAMPLES GENERATED NEGATIVE RESULTS FOR THE SARS-COV-2, INFLUENZA A AND INFLUENZA B ASSAY RUN ON THE COBAS® LIAT ANALYZER. REPEAT TESTING OF A NEWLY COLLECTED NASAL SWABS, WAS PERFORMED WITH THE COBAS® 6800 ANALYZER AT THE PARTNER LAB AND GENERATED POSITIVE RESULTS. THE SAMPLES FOR THE INITIAL TESTS WERE COLLECTED USING THE COBAS PCR UNI SWAB, AND FOR THE REPEAT TESTING THE SAMPLES WERE COLLECTED USING NASAL SWABS WITH AN UNKNOWN MEDIA TYPE. THE METHOD SHEET INDICATES THE 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. NO HARM ALLEGED. THE INVESTIGATION IS ONGOING. PER THE FDA GUIDANCE THREE (3) MDRS WILL BE FILED; ONE PER PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892630 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 10308Y

    Patients

    Seq Age Sex Outcome Treatment
    1