BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13261509 · Received January 14, 2022

    Report

    Report Number
    2243471-2022-00086
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    December 15, 2021
    Report Date
    January 14, 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
    LO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM SLOVAKIA ALLEGED THAT THEY RECEIVED POTENTIAL FALSE POSITIVE RESULTS FOR 3 PATIENTS¿ SAMPLES WHEN TESTED WITH THE COBAS® SARS-COV-2 & INFLUENZA A/B (SCFA) ASSAY AND OTHER PLATFORMS. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER ISSUE. UPON INVESTIGATION, THE OPTICAL DATA SHOWED FEW TEMPORARY DISTURBANCES INDICATING POTENTIAL LEAK EVENTS. OPTICAL BACKGROUND DATA WENT BACK TO EXPECTED VALUES AFTER THAT. THESE EVENTS DID NOT AFFECT THE PERFORMANCE OF THE ANALYZER. THROUGHOUT THE DATA ANALYSIS, A SYSTEMATIC ISSUE WAS NOT OBSERVED AND A PRODUCT PROBLEM WAS NOT FOUND. SAMPLES WITH LOW TITER RESULTS MAY NOT BE REPRODUCIBLE ON A LESS SENSITIVE INSTRUMENT. THE LIAT SCFA LIMIT OF DETECTION (LOD) FOR SARS-COV-2 ON THE METHOD SHEET INDICATES: 0.012 TCID50/ML, 12 COPIES/ML, 5400 NDU/ML. LIAT SCFA SARS-COV-2 TEST DETECTS REGIONS OF THE ORF1A/B ALONG WITH THE N GENE OF THE SARS-COV-2. DETECTION OF EITHER OR BOTH TARGETS IS CONSIDERED A POSITIVE SARS-COV-2. VERY LOW VIRAL LOAD SPECIMENS THAT ARE NEAR THE ASSAY LOD MAY NOT GENERATE CONSISTENT RESULTS UPON REPEAT TESTING ACCORDING TO EXPECTED STATISTICAL VARIANCES IN DETECTION. GIVEN THESE DIFFERENCES, RESULTS WITH ONE ASSAY MAY NOT BE REPRODUCIBLE WITH A DIFFERENT ASSAY. ADDITIONALLY, MEDIA WITH A DIFFERENT CHEMICAL COMPOSITION COULD CONTAIN SUBSTANCES THAT COULD INTERFERE WITH TEST OPERATION AND MAY IMPACT ASSAY PERFORMANCE. IF THE VOLUME OF COLLECTION MEDIA IS NOT IDENTICAL TO ON-LABEL COLLECTION KIT (3ML), THEN ANY POTENTIAL INTERFERING SUBSTANCES COLLECTED WILL BE MORE CONCENTRATED AND INCREASE THE RATE OF INACCURATE RESULTS. THE APPROVED ON-LABEL COLLECTION KITS HAVE BEEN TESTED AND CONFIRMED TO BE COMPATIBLE WITH THE SCFA ASSAY. FURTHERMORE, IT IS POSSIBLE THAT A LOW LEVEL OF LABORATORY CONTAMINATION COULD CAUSE A LOW VIRAL LOAD IN A SAMPLE. IN GENERAL, NO SYSTEM-RELATED ISSUE WAS FOUND IN THE DATA AND NO POTENTIAL FALSE-POSITIVE RESULTS WERE FOUND IN THE DATASET. THE ANALYZER IS WORKING AS EXPECTED AND NO PRODUCT PROBLEM FOUND. (B)(6). (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 SLOVAKIA ALLEGED THAT THEY RECEIVED POTENTIAL FALSE POSITIVE RESULTS FOR 3 PATIENTS¿ SAMPLES WHEN TESTED WITH THE COBAS® SARS-COV-2 & INFLUENZA A/B (SCFA) ASSAY AND OTHER PLATFORMS. PATIENT SAMPLES WERE COLLECTED USING NASOPHARYNGEAL SWABS AND PLACED IN AN RNA /DNA COLLECTION KIT WITH A TEST TUBE CONTAINING ZYMO RESEARCH CORP. FLUID 1ML. THIS IS NOT A RECOMMENDED PRACTICE FOR SAMPLE COLLECTION. AS PER THE METHOD SHEET, COLLECT SPECIMEN USING A STERILE FLOCKED SWAB WITH A SYNTHETIC TIP ACCORDING TO APPLICABLE MANUFACTURER INSTRUCTIONS AND/OR STANDARD COLLECTION TECHNIQUE USING 3 ML OF VIRAL TRANSPORT MEDIA OR STERILE 0.9% PHYSIOLOGICAL SALINE. THE CUSTOMER CONFIRMED THERE WERE NO ALLEGATION OF HARM TO THE PATIENTS. THREE (3) MDRS WILL BE FILED ONE FOR EACH SAMPLE AS PER FDA GUIDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017863 COBAS® LIAT® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 10913U

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown