BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® LIAT® SARS-COV-2 & INFLUENZA A/B

    MDR report key: 12916770 · Received December 2, 2021

    Report

    Report Number
    2243471-2021-03797
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 3, 2021
    Report Date
    January 10, 2022
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QLT
    PMA / PMN Number
    EUA201779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED UPON THE COMPLETION OF THE INVESTIGATION. CN-(B)(4).

    Additional Manufacturer Narrative · 0

    NO PRODUCT PROBLEM RELATED TO THE CUSTOMER ALLEGATION WAS IDENTIFIED. NO PCR CURVE ABNORMALITIES ARE SEEN WITH EITHER OF THE TWO POSITIVE RUNS; BOTH RUNS APPEAR TO HAVE TRUE TARGET AMPLIFICATION IN THE SARS-COV-2 CHANNEL. THIS IS CONSISTENT WITH A LOW TITER SAMPLES, NEAR THE LIMIT OF DETECTION (LOD) FOR THE TEST. NEAR LOD, SAMPLE RESULTS CAN BE EXPECTED TO WAIVER UPON RETEST. (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. THE CUSTOMER ALLEGED DISCREPANT RESULTS GENERATED FOR THE COBAS® SARS-COV-2 & INFLUENZA A/B (SCFA) ASSAY. A CUSTOMER FROM THE UNITED STATES ALLEGED THAT THEY RECEIVED POTENTIAL FALSE POSITIVE RESULTS FOR PATIENTS¿ SAMPLES TESTED WITH THE COBAS® SARS-COV-2 & INFLUENZA A/B (SCFA) ASSAY. THE CUSTOMER REPORTED THAT ON NOVEMBER 01, 2021 DURING RUN # 3570 A PATIENT¿S SAMPLE TESTED WITH KIT LOT # 01214U GENERATED A SARS-COV-2 POSITIVE, INFLUENZA A NEGATIVE, INFLUENZA B NEGATIVE RESULT WHEN ANALYZED ON COBAS® LIAT® SYSTEM (S/N (B)(4)). ON (B)(6) 2021 DURING RUN # 2951 A 2ND PATIENT¿S SAMPLE TESTED WITH KIT LOT # 01215T GENERATED SARS-COV-2 POSITIVE, INFLUENZA A NEGATIVE, INFLUENZA B NEGATIVE RESULTS WHEN ANALYZED ON COBAS® LIAT® SYSTEM (S/N (B)(4)). BOTH PATIENTS¿ SAME SAMPLES WERE REPEATED ON DIFFERENT COBAS® LIAT® SYSTEMS (S/N NOT PROVIDED) THAT GENERATED SARS-COV-2 NEGATIVE, INFLUENZA A NEGATIVE, INFLUENZA B NEGATIVE RESULTS. ON (B)(6) 2021 021 BOTH PATIENTS¿ SAME SAMPLES WERE REPEATED ON A DIFFERENT PLATFORM THE CEPHEID THAT GENERATED SARS-COV-2 NEGATIVE RESULTS FOR EACH PATIENT¿S SAMPLE. PATIENT SAMPLE WAS COLLECTED USING NASOPHARYNGEAL IN BD UNIVERSAL TRANSPORT MEDIA. THE CUSTOMER CONFIRMED THERE WERE NO ALLEGATION OF HARM TO THE PATIENTS. THE RESULTS WERE REPORTED OUT TO THE PATIENTS AND/OR PERSONNEL TREATING THE PATIENTS. THE INVESTIGATION TO ASSESS THE CUSTOMER ALLEGATION HAS NOT YET BEEN COMPLETED. TWO (2) MDRS WILL BE FILED ONE FOR EACH SAMPLE AS PER FDA GUIDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812744 COBAS® LIAT® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 01215T

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown