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: 12081817 · Received June 28, 2021

    Report

    Report Number
    2243471-2021-02202
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    June 5, 2021
    Report Date
    August 12, 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
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION ON THE REAGENT KIT LOT DID NOT IDENTIFY AND PRODUCT PROBLEM. THE ALLEGED SAMPLE WAS A NASOPHARYNGEAL SWAB AND THROAT SWAB COLLECTED IN DNA/RNA PRESERVATION KIT DEWEI MEDICAL EQUIPMENT CO., LTD. THE PRODUCTS¿ METHOD SHEETS 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. IT IS ALSO POSSIBLE THE SAMPLE CONTAINS VIRAL MATERIAL NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY, EITHER FROM LOW TITER SAMPLES OR A LOW LEVEL OF LABORATORY CONTAMINATION. HOWEVER, WITHOUT THE DATA FROM THE INSTRUMENT, THIS CASE CANNOT BE CONFIRMED. (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 DISCREPANT SARS-COV-2 RESULTS FOR PATIENT SAMPLE WHEN USING THE COBAS LIAT SARS-COV-2 AND INFLUENZA A/B TEST COMPARED TO THE RETEST RESULTS. THE ALLEGED SAMPLE GENERATED A SARS-COV-2 POSITIVE, FLU A NEGATIVE AND FLU B NEGATIVE RESULT IN THE INITIAL TEST ON THE COBAS LIAT SYSTEM (SN# (B)(4)). THIS SAMPLE WAS RETESTED ON ANOTHER COBAS LIAT SYSTEM (SN# (B)(4)), AND GENERATED NEGATIVE RESULT FOR THE THREE TARGETS (SARS-COV-2, FLU A AND FLU B). IN ADDITION, THE SAME SAMPLE WAS RETESTED FOR THIRD TIME ON A A GENEXPERT SYSTEM (CEPHEID), AND GENERATED SARS-COV-2 NEGATIVE RESULT. THE SAMPLE WAS NASOPHARYNGEAL AND THROAT SWABS. THE PRODUCTS¿ METHOD SHEETS 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 0.9% PHYSIOLOGICAL SALINE SOLUTION. TESTING OF OTHER SAMPLE OR MEDIA TYPES MAY LEAD TO INACCURATE RESULT. THE NEGATIVE RESULT WAS RELEASED. NO HARM WAS ALLEGED. AN INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977804 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 10222Y

    Patients

    Seq Age Sex Outcome Treatment
    1