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: 12047062 · Received June 22, 2021

    Report

    Report Number
    2243471-2021-02088
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    May 27, 2021
    Report Date
    July 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
    US
    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. A REVIEW OF THE DATA REVEALED LATE CT VALUES INDICATIVE OF A SAMPLE NEAR THE LIMIT OF DETECTION (LOD). LOD SAMPLES ARE EXPECTED TO WAIVER BETWEEN POSITIVE AND NEGATIVE UPON REPEAT. (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 US ALLEGED THE GENERATION OF DISCREPANT SARS-COV-2 RESULTS FOR ONE PATIENT WHEN USING THE COBAS LIAT SARS-COV-2 AND INFLUENZA A/B TEST COMPARED TO THE RETEST RESULTS. THE PATIENT SAMPLE WAS TESTED AT THE SAME TIME ON CEPHEID AND ON COBAS LIAT SYSTEM (SN (B)(4)), GENERATED A SARS-COV-2 NEGATIVE RESULT ON COBAS LIAT SYSTEM AND A SARS-COV-2 POSITIVE RESULT ON CEPHEID. THE SAME SAMPLE WAS RETESTED ON A DIFFERENT COBAS LIAT SYSTEM (SN (B)(4)), GENERATED A SARS-COV-2 POSITIVE RESULT. THE CUSTOMER RETESTED THE SAME PATIENT SAMPLE FOR THE THIRD TIME ON THE COBAS LIAT SYSTEM (SN (B)(4)), GENERATED A NEGATIVE RESULT. THE POSITIVE SARS-COV-2 RESULT WAS RELEASED. NO HARM WAS ALLEGED. AN INVESTIGATION IS ON GOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942518 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 00928Y

    Patients

    Seq Age Sex Outcome Treatment
    1