BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 & INFLUENZA A/B

    MDR report key: 14439849 · Received May 19, 2022

    Report

    Report Number
    2243471-2022-00484
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    November 10, 2021
    Report Date
    May 19, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE PROVIDED DATA INDICATED THAT THE ALLEGED SAMPLE IS A LOW TITER SAMPLE, AT/NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY. VERY LOW VIRAL LOAD SPECIMENS THAT ARE NEAR THE ASSAY LOD MAY NOT GENERATE CONSISTENT RESULTS UPON REPEAT TESTING ACCORDING TO EXPECTED STATISTICAL VARIANCES IN DETECTION. FACILITY NAME IS TRUNCATED DUE TO CHARACTER LIMIT. FACILITY FULL NAME: (B)(4). NO SYSTEMATIC ISSUE OBSERVED. NO PRODUCT PROBLEM FOUND. (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED DEVICE CODE TO A090806 (4029) NON REPRODUCIBLE RESULTS. ----- (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 ALLEGED DISCREPANT RESULTS FOR 5 PATIENT SAMPLES WHEN USING THE COBAS® SARS-COV-2 & INFLUENZA A/B ASSAY FOR USE ON THE COBAS® LIAT® SYSTEM. THE 5 SAMPLES WERE INITIALLY TESTED WITH THE COBAS® LIAT® SYSTEM AND GENERATED SARS-COV-2 POSITIVE, INFLUENZA A NEGATIVE AND INFLUENZA B NEGATIVE RESULTS. ALL 5 SAMPLES WERE RETESTED ON ANOTHER PLATFORM: PANTHER (HOLOGIC) RESULTING IN NEGATIVE RESULTS SARS-COV-2 RESULTS. IT IS UNCLEAR WHICH RESULTS WERE REPORTED OUT. NO APPARENT HARM OR INJURY OCCURRED IN RELATION TO THE EVENT. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER¿S ALLEGATION. PER FDA¿S EUA GUIDANCE, 5 MDRS WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977301 COBAS® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 20124L

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown