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: 11904400 · Received May 28, 2021

    Report

    Report Number
    2243471-2021-01531
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    April 27, 2021
    Report Date
    May 28, 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 DISCREPANT RESULTS WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. THE COBAS LIAT GENERATED NEGATIVE RESULTS BUT THE PATIENT WAS POSITIVE FOR SARS-COV-2 WHEN TESTED ON OTHER PLATFORMS. AN INVESTIGATION WAS CONDUCTED AND DID NOT IDENTIFY ANY PRODUCT PROBLEM. THE DISCREPANCY IS LIKELY DUE TO LOW TITER SAMPLES NEAR THE LIMIT OF DETECTION AND DUE TO DIFFERENCES IN ASSAY TECHNOLOGY AND THEIR SENSITIVITIES. (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 WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. THE PATIENT INITIALLY GENERATED A POSITIVE RESULT ON A DIFFERENT PLATFORM BUT WAS NEGATIVE WHEN TESTED ON THE COBAS LIAT. THE PATIENT LATER WAS TESTED USING AN IN-HOUSE ASSAY AND GENERATED A POSITIVE RESULT TWICE. THE POSITIVE RESULT WAS RELEASED AND THE PATIENT WAS TREATED ACCORDINGLY. DURING THIS TIME THE PATIENT WAS PLACED IN QUARANTINE. NO HARM WAS ALLEGED. ACCORDING TO THE CUSTOMER, SAMPLES ARE COLLECTED USING THE PMW VIRAL TRANSPORT MEDIUM RT FROM XCELL THERAPEUTIC INC. AND STORED AT 2-8C. THE SAMPLE WAS TESTED IMMEDIATELY AFTER COLLECTION. PLEASE NOTE, THE USE OF NON-VALIDATED COLLECTION TUBES IS NOT A RECOMMENDED PRACTICE. PER 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 CONDUCTED AND DID NOT IDENTIFY ANY PRODUCT PROBLEM. THE LIAT RESULTS ARE LIKELY LOW TITER SAMPLES INDICATIVE OF A LOW VIRAL LOAD NEAR THE LIMIT OF DETECTION. LOD SAMPLES ARE EXPECTED TO WAIVER BETWEEN POSITIVE AND NEGATIVE WITH REPEAT TESTING. IN ADDITION, THE DISCREPANCY COULD BE DUE TO DIFFERENCES IN TECHNOLOGIES BETWEEN THE PLATFORMS USED. ASSAYS CAN DIFFER IN SENSITIVITY AND THEIR ABILITY TO DETECT VIRAL LOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801139 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 10104X

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR