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: 11531620 · Received March 19, 2021

    Report

    Report Number
    2243471-2021-00547
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    January 20, 2021
    Report Date
    March 19, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY NAME TRUNCATED DUE TO CHARACTER LIMIT: (B)(6) A CUSTOMER ALLEGED A DISCREPANT SARS-COV-2 RESULT FOR A SINGLE PATIENT WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST FOR USE ON THE COBAS® LIAT® SYSTEM. THE ORIGINAL SAMPLE GENERATED A POSITIVE SARS-COV-2 RESULT BUT 3 SUBSEQUENT NEW COLLECTIONS TESTED ON THREE DIFFERENT INSTRUMENTS WERE NEGATIVE. THE DISCREPANCY COULD BE A RESULT OF NON-RECOMMENDED COLLECTION PRACTICES OR DUE TO THE SAMPLE BEING NEAR THE LIMIT OF DETECTION (LOD). A SAMPLE AT LOD MAY NOT BE REPRODUCIBLE WITH THE SAME OR WITH OTHER PLATFORMS, ESPECIALLY THOSE THAT ARE LESS SENSITIVE LIKE THE REPEAT TESTING USED. NO PRODUCT PROBLEM IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    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 ALLEGED A DISCREPANT SARS-COV-2 RESULT FOR A SINGLE PATIENT WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST FOR USE ON THE COBAS® LIAT® SYSTEM. ON THE LIAT, A PATIENT SAMPLE GENERATED A POSITIVE SARS-COV-2, AND NEGATIVE FLU A/B RESULT WHICH WAS REPORTED IN REAL-TIME. 3 NEW SAMPLE COLLECTIONS WERE TESTED ON 3 DIFFERENT COMPETITOR ASSAYS WHICH ALL YIELDED NEGATIVE RESULTS. ACCORDING TO THE CUSTOMER, THE PATIENT SAMPLE WAS COLLECTED USING A NASOPHARYNGEAL SPECIMEN AND THE TRAFALGAR MEDIUM. NOTE, THIS IS NOT CONSIDERED A RECOMMENDED PRACTICE. ACCORDING TO THE METHOD SHEET, SAMPLES SHOULD BE COLLECTED 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. AN INVESTIGATION WAS COMPLETED TO EVALUATE THE CUSTOMER ISSUE WHICH DID NOT IDENTIFY ANY PRODUCT PROBLEM. THE SCFA REAGENT LOT 00918Z INVESTIGATION SHOWED NO TRENDS OR PRODUCT NON-CONFORMANCES AND IS PERFORMING AS EXPECTED. DATA REVIEW OF THE INSTRUMENT INFORMATION FOR THE POSITIVE SARS-COV-2 RUN INDICATES A VERY LATE CT VALUE AND WEEK AMPLIFICATION FOR THE SARS-COV-2 TARGET WHICH IS CONSISTENT WITH RESULTS NEAR THE LIMIT OF DETECTION (LOD) FOR THE THIS ASSAY. NO ABNORMALITIES IN THE CURVES WERE SEEN. A SAMPLE AT LOD MAY NOT BE REPRODUCIBLE WITH THE SAME OR WITH OTHER PLATFORMS, ESPECIALLY THOSE THAT ARE LESS SENSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420014 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 00918Z

    Patients

    Seq Age Sex Outcome Treatment
    1