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: 12170685 · Received July 14, 2021

    Report

    Report Number
    2243471-2021-02486
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 14, 2021
    Report Date
    September 2, 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

    ALTHOUGH REQUESTED THE CUSTOMER HAS NOT PROVIDED ANY DATA OR INFORMATION RELATED TO THE ALLEGATION. WITHOUT ANY DATA, THE INVESTIGATION CANNOT DETERMINE IF THOSE SAMPLES ARE NEAR THE LIMIT OF DETECTION (LOD). NO PRODUCT ISSUE WAS OBSERVED. THE CUSTOMER'S ALLEGATION IS SUBSTANTIATED. (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED DEVICE CODE TO A090806 NON REPRODUCIBLE RESULTS. CN-613876.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED UPON THE COMPLETION OF THE INVESTIGATION. (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 US ALLEGED DISCREPANT RESULTS GENERATED ON 3 PATIENT SAMPLES WHEN USING A COBAS® SARS-COV-2 AND INFLUENZA A/B NUCLEIC ACID TEST FOR USE ON THE COBAS® LIAT® SYSTEM, WHEN COMPARED TO THE RESULTS GENERATED WITH THE GENEXPERT CEPHEID SYSTEM. THE 3 INITIAL PATIENT SAMPLES GENERATED SARS-COV2 POSITIVE; FLU A NEGATIVE AND FLU B POSITIVE. FURTHERMORE, THE SAME 3 SAMPLES WERE RETESTED WITH THE GENEXPERT CEPHEID SYSTEM AND GENERATED NEGATIVE RESULTS FOR ALL 3 TARGETS. BOTH INITIAL TEST RESULTS AND THE RETEST WERE REPORTED TO THE PATIENTS. NO HARM IS ALLEGED. PER THE FDA GUIDANCE THREE (3) MDRS WILL BE FILED ONE PER PATIENT. AN INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062289 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1