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: 11867642 · Received May 21, 2021

    Report

    Report Number
    2243471-2021-01427
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 22, 2021
    Report Date
    June 22, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE ANALYZER RUN DATA SHOWED THAT THE ALLEGED RUNS HAD STABLE AMPLIFICATION CURVES FOR THE SARS-COV-2 TARGET, INDICATING THEY WERE VALID POSITIVE RESULTS. NO CURVES ANOMALIES FROM THE SYSTEM PERSPECTIVE WERE OBSERVED. FURTHER INVESTIGATION ON THE REAGENT KIT DID NOT IDENTIFY ANY PRODUCT ISSUES. (B)(6). (B)(4)

    Additional Manufacturer Narrative · 0

    CORRECTED REAGENT BATCH NUMBER FROM 01102Z TO 10111X. SAMPLE 1 (BAL SAMPLE) USED LOT 01102Z. SAMPLE 2 (NASAL/THROAT SWAB) USED LOT 10111X. (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 ON 2 SAMPLES WHEN USING THE COBAS® SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS® LIAT® SYSTEM. SAMPLE (1), A BRONCHOALVEOLAR LAVAGE (BAL) SAMPLE, TESTED POSITIVE FOR SARS-COV-2 ON THE COBAS® LIAT SYSTEM. A REPEAT TEST WAS PERFORMED ON AN UNKNOWN PLATFORM AT A PARTNER LAB. THE RESULT WAS NEGATIVE. THE CUSTOMER INDICATED THAT DUE TO THE CHEST X-RAY RESULT AND BLOOD VALUES THE DOCTORS REQUESTED A CONFIRMATION TEST FOR THE BRONCHOALVEOLAR LAVAGE (BAL) FLUID SAMPLE. SAMPLE (2), A NASAL/THROAT SAMPLE, INITIALLY TESTED POSITIVE FOR SARS-COV-2, UPON A REPEAT ON THE SAME SYSTEM THE RESULT WAS CONFIRMED AS POSITIVE. A REPEAT TEST PERFORMED ON AN UNKNOWN PLATFORM AT A PARTNER LAB GENERATED A NEGATIVE RESULT FOR SARS-COV-2. IT WAS INDICATED THAT SAMPLE (1) WAS A BRONCHOALVEOLAR LAVAGE (BAL) FLUID SAMPLE AND SAMPLE (2) WAS A NASAL/THROAT SAMPLE. THE METHOD SHEET OF COBAS® SARS-COV-2 & INFLUENZA A/B TEST INDICATES: 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. BOTH PATIENTS WERE TEMPORARILY PLACED ON QUARANTINE, THEN RELEASED, ONCE THE RETESTS WERE CONFIRMED TO BE NEGATIVE. NO HARM IS ALLEGED. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER ISSUE. PER THE FDA GUIDANCE, 2 MDRS WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763412 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 10111X

    Patients

    Seq Age Sex Outcome Treatment
    1