BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIDEL LYRA SARS-COV-2 ASSAY (M120)

    MDR report key: 11694707 · Received April 20, 2021

    Report

    Report Number
    1000122536-2021-00001
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    April 28, 2020
    Report Date
    April 16, 2021
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QJR
    UDI-DI
    30014613339090
    PMA / PMN Number
    EUA200016
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATIONAL SUMMARY: THE CUSTOMER STATED THE ISSUE WAS RELATED TO THEIR INTERNAL PROCESS RATHER THAN A QUALITY ISSUE FOR THE LYRA ASSAY. NO INVESTIGATION IS REQUIRED. THE CUSTOMER HAS OUTLINED THEIR STEPS FOR RISK MITIGATION.

    Description of Event or Problem · 1

    FALSE POSITIVE: CUSTOMER SELF-REPORTED PROCESSING ISSUE THAT LEAD TO FALSE POSITIVE RESULTS ON THE LYRA SARS-COV-2 ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593807 QUIDEL LYRA SARS-COV-2 ASSAY (M120) LYRA SARS-COV-2 ASSAY QJR QUIDEL CORPORATION Coronavirus 30014613339090

    Patients

    Seq Age Sex Outcome Treatment
    1