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: 12089491 · Received June 29, 2021

    Report

    Report Number
    2243471-2021-02203
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    May 29, 2021
    Report Date
    June 29, 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

    (B)(6). A CUSTOMER FROM (B)(6) ALLEGED A DISCREPANT RESULT FOR A SINGLE PATIENT WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. NO HARM WAS ALLEGED. AN INVESTIGATION WAS PERFORMED WHICH DID NOT IDENTIFY ANY PRODUCT ISSUE. A REVIEW OF THE DATA DID NOT REVEAL ANY ABNORMALITIES. IT IS POSSIBLE THE DISCREPANCY IS DUE TO DIFFERENCES IN TECHNOLOGIES BETWEEN PLATFORMS USED. ADDITIONALLY, THE USE OF NON-RECOMMENDED SAMPLE COLLECTION PRACTICES CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE PRODUCT IS FUNCTIONING AS INTENDED.

    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 A DISCREPANT RESULT FOR A SINGLE PATIENT WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. NO HARM WAS ALLEGED. THE ALLEGED SAMPLE INITIALLY GENERATED A POSITIVE SARS-COV-2 RESULT. THE SAME SAMPLE WAS RETESTED BOTH ON THE SAME PLATFORM AND ANOTHER ASSAY WHICH BOTH YIELDED NEGATIVE RESULTS FOR ALL TARGETS. THE INITIAL POSITIVE RESULT WAS NOT RELEASED. ACCORDING TO THE CUSTOMER, SAMPLES ARE COLLECTED USING (B)(6) VIRAL SAMPLING TUBE (INACTIVATED, 3.0 ML) AND ASAN TRANSPORT MEDIUM WHICH NOT CONSIDERED A VALIDATED COLLECTION METHOD. PER THE METHOD SHEET, SPECIMENS 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 PERFORMED WHICH DID NOT IDENTIFY ANY PRODUCT ISSUE. A REVIEW OF THE DATA DID NOT REVEAL ANY ABNORMALITIES. IT IS POSSIBLE THE DISCREPANCY IS DUE TO DIFFERENCES IN TECHNOLOGIES BETWEEN PLATFORMS USED. ADDITIONALLY, THE USE OF NON-RECOMMENDED SAMPLE COLLECTION PRACTICES CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE PRODUCT IS FUNCTIONING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981150 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 10308X

    Patients

    Seq Age Sex Outcome Treatment
    1