BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS SARS-COV-2 & INFLUENZA A/B FOR USE ON THE COBAS 6800-8800 SYSTEM

    MDR report key: 11816911 · Received May 13, 2021

    Report

    Report Number
    2243471-2021-01256
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 15, 2021
    Report Date
    May 12, 2021
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QJR
    PMA / PMN Number
    EUA202635
    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

    NO KIT LOT INFORMATION OR DATA WERE PROVIDED, ALTHOUGH REQUESTED. NO PRODUCT PROBLEM WAS IDENTIFIED BASED ON THE INVESTIGATION THAT WAS PERFORMED. (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 IN THE US ALLEGED THE GENERATION OF DISCREPANT SARS-COV-2 RESULTS FOR TWO PATIENTS WHEN TESTED WITH THE COBAS 6800/8800 SARS-COV-2 & FLU A/B TEST AND THE COBAS LIAT SARS-COV-2 & FLU A/B TEST. FOR EACH PATIENT, A SAMPLE WAS COLLECTED AND SENT TO A REFERENCE LAB FOR TESTING WITH THE COBAS 6800/8800 SARS-COV-2 & FLU A/B TEST. SAMPLE 1 GENERATED A NEGATIVE RESULT FOR SARS-COV-2 AND SAMPLE 2 GENERATED A POSITIVE RESULT FOR SARS-COV-2. AFTER THE SAMPLES WERE SENT TO THE REFERENCE LAB, A DIFFERENT COLLECTION (BD CATALOG NUMBER 220220) FROM EACH PATIENT WAS TESTED AT THE CUSTOMER SITE WITH THE COBAS LIAT SARS-COV-2 & FLU A/B TEST. SAMPLE 1 GENERATED A POSITIVE SARS-COV-2 RESULT AND SAMPLE 2 GENERATED A NEGATIVE SARS-COV-2 RESULT. THE C6800/8800 RESULTS FOR BOTH SAMPLES WERE RELEASED FROM THE REFERENCE LAB. IN EACH CASE, THE POSITIVE SARS-COV-2 RESULTS WERE REPORTED TO THE PROVIDER. NO HARM OR INJURY WAS INDICATED. ALTHOUGH REQUESTED, SPECIFIC INFORMATION RELATING TO THE REFERENCE LAB, THE KIT LOT INFORMATION FOR THE COBAS 6800/8800 SARS-COV-2 & FLU A/B TEST KIT LOT USED, AND THE TYPE OF SAMPLE COLLECTIONS TESTED AT THE REFERENCE LAB COULD NOT BE PROVIDED. TWO MDRS WILL BE FILED, ONE FOR EACH PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718271 COBAS SARS-COV-2 & INFLUENZA A/B FOR USE ON THE COBAS 6800-8800 SYSTEM REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR