BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIDEL SOLANA SARS-COV-2 ASSAY (M313)

    MDR report key: 11698420 · Received April 20, 2021

    Report

    Report Number
    1000122536-2021-00021
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 17, 2021
    Report Date
    April 20, 2021
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QJR
    UDI-DI
    30014613339656
    PMA / PMN Number
    EUA203087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATIONAL SUMMARY: ALL SAMPLES TESTED WERE NEGATIVE FOR SARS ON THE SOLANA SARS ASSAY. ALL RESULTS WERE VALID, AND NO FALSE POSITIVES WERE DETECTED FOR ALL PATIENT SAMPLES. IN ADDITION, THE POSITIVE CONTROL FOR THE ASSAY REPORTED AS POSITIVE.

    Description of Event or Problem · 1

    CROSS REACTIVITY: CUSTOMER REPORTING POSITIVE COV ON SOLANA, NEGATIVE ON BIOFIRE. BIOFIRE REPORTED POSITIVE RHINO/ENTERO VIRUS. CUSTOMER CONCERNED ABOUT INTERFERENCE/CROSS REACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589608 QUIDEL SOLANA SARS-COV-2 ASSAY (M313) SOLANA SARS-COV-2 ASSAY QJR QUIDEL CORPORATION Coronavirus 30014613339656

    Patients

    Seq Age Sex Outcome Treatment
    1