BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 & INFLUENZA A/B

    MDR report key: 14518627 · Received May 26, 2022

    Report

    Report Number
    2243471-2022-00509
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    May 16, 2022
    Report Date
    June 15, 2022
    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 ONGOING. A FOLLOW-UP REPORT WILL BE FILED UPON THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 0

    FOR BOTH SAMPLES, DELAYED AMPLIFICATION CAN BE OBSERVED FOR THE SARS TARGET, INDICATING THE SAMPLE HAD A LOW VIRAL CONCENTRATION. FURTHER REVIEW OF THE DATASET SHOWS THE CUSTOMER HANDLES A LARGE AMOUNT OF INFLUENZA A AND SARS REACTIVE SAMPLES, IT IS POSSIBLE THAT THE DISCREPANCY, IN THIS CASE, OCCURRED DUE TO CONTAMINATION AT THE CUSTOMER SITE. NO PRODUCT PROBLEM OR SYSTEMIC ISSUE WAS IDENTIFIED. DEVICE CODE WAS UPDATED TO A090806 NON REPRODUCIBLE RESULTS (4029).

    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 ALLEGED DISCREPANT RESULTS USING THE COBAS® SARS-COV-2 & INFLUENZA A/B TEST ASSAY FOR USE ON THE COBAS® LIAT® SYSTEM. THE ALLEGED SAMPLES INITIALLY GENERATED SARS-COV-2 POSITIVE AND INFLUENZA A POSITIVE RESULTS. THE SAME SAMPLES WERE REPEATED WITH THE SAME DEVICE (SAMPLE 1 WAS REPEATED TWICE, SAMPLE 2 ONLY ONCE) AND GENERATED NEGATIVE RESULTS FOR ALL THREE TARGETS. THE RESULTS WERE NOT REPORTED TO THE PATIENTS. NO APPARENT HARM OR INJURY OCCURRED IN RELATION TO THE EVENT. AN INVESTIGATION IS ONGOING AND RESULTS ARE NOT YET AVAILABLE. PER FDA¿S EUA GUIDANCE, 2 MDRS WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2639672 COBAS® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 20214L

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female