BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® LIAT® SARS-COV-2 & INFLUENZA A/B

    MDR report key: 12639895 · Received October 15, 2021

    Report

    Report Number
    2243471-2021-03544
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    September 15, 2021
    Report Date
    November 15, 2021
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QLT
    PMA / PMN Number
    EUA201779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE FILED UPON THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL FOLLOW UP TO PROVIDE THE INVESTIGATION CONCLUSION TO 2243471-2021-03544. AN INVESTIGATION ON THE REAGENT KIT LOT DID NOT IDENTIFY ANY PRODUCT PROBLEM. THE CUSTOMER USED A COPAN, LOT B004032, CN 3C047N COLLECTION KIT, NOTE THAT THIS IS OFF-LABEL. GIVEN DATA WAS NOT PROVIDED, THE ALLEGATION COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE ESTABLISHED. (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 THE UNITED STATES ALLEGED A DISCREPANT RESULT FOR ONE PATIENT SAMPLE WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST FOR USE ON THE COBAS® LIAT® SYSTEM. THE ALLEGED SAMPLE GENERATED A NEGATIVE SARS-COV-2, NEGATIVE INFLUENZA A, POSITIVE INFLUENZA B RESULT ON THE COBAS LIAT SYSTEM. THE SAMPLE WAS RETESTED ON THE CEPHEID PLATFORM AND GENERATED A NEGATIVE SARS-COV-2, NEGATIVE INFLUENZA A, & B AND POSITIVE RSV RESULT. THE POSITIVE RSV RESULT WAS REPORTED TO THE PHYSICIAN. FURTHER INVESTIGATION HAS BEEN INITIATED AND IS ONGOING. PER FDA GUIDANCE, ONE(1) MDR WILL BE FILED, ONE PER DISCREPANT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1538221 COBAS® LIAT® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 10217Y

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown