BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIDEL LYRA DIRECT SARS-COV-2 ASSAY (M124)

    MDR report key: 11698406 · Received April 20, 2021

    Report

    Report Number
    1000122536-2021-00008
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    December 1, 2020
    Report Date
    April 21, 2021
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QJR
    PMA / PMN Number
    EUA200423
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CATEGORIZATION: OFF-LABEL USE OF DEVICE; USING LYRA PROCESS BUFFER TO RE-EXTRACT FOR CDC METHOD ASSAY. THERMOCYCLER: APPLIED BIOSYSTEMS® 7500 FAST DX.. OUTCOME: UNABLE TO TROUBLESHOOT THIS EVENT AS CUSTOMER NEVER SEND RAW DATA FOR REVIEW. CUSTOMER RESOLVED ISSUE WITH ADDITIONAL ASSISTANCE FROM QUIDEL. IFU STATES THAT " NEGATIVE RESULTS SHOULD BE TREATED AS PRESUMPTIVE AND CONFIRMED WITH AN FDA AUTHORIZED MOLECULAR ASSAY THAT UTILIZES A CHEMICAL LYSIS STEP FOLLOWED BY SOLID PHASE EXTRACTION OF NUCLEIC ACID, IF NECESSARY" IFU LIMITATIONS SECTION: · NEGATIVE RESULTS SHOULD BE TREATED AS PRESUMPTIVE AND CONFIRMED WITH AN FDA AUTHORIZED MOLECULAR ASSAY THAT UTILIZES A CHEMICAL LYSIS STEP FOLLOWED BY SOLID PHASE EXTRACTION OF NUCLEIC ACID, IF NECESSARY, FOR CLINICAL MANAGEMENT. · A TRAINED HEALTH CARE PROFESSIONAL SHOULD INTERPRET ASSAY RESULTS IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL SIGNS AND SYMPTOMS, AND THE RESULTS OF OTHER DIAGNOSTIC TESTS.

    Description of Event or Problem · 0

    FALSE NEGATIVE: CUSTOMER REACHED OUT TO REPORT FN LYRA DIRECT VERSUS CDC METHOD; INQUIRED ABOUT MODIFYING SARS THRESHOLDS.

    Description of Event or Problem · 1

    FALSE NEGATIVE: CUSTOMER REACHED OUT TO REPORT FN LYRA DIRECT VERSUS CDC METHOD; INQUIRED ABOUT MODIFYING SARS THRESHOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590783 QUIDEL LYRA DIRECT SARS-COV-2 ASSAY (M124) LYRA DIRECT SARS-COV-2 ASSAY QJR QUIDEL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1