BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIDEL SOLANA SARS-COV-2 ASSAY (M313)

    MDR report key: 11698414 · Received April 20, 2021

    Report

    Report Number
    1000122536-2021-00030
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 22, 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: PATIENT SAMPLES WERE NEGATIVE FOR SARS ON THE SOLANA SARS ASSAYS. ALL RESULTS WERE VALID, AND NO FALSE POSITIVES WERE DETECTED FOR ALL PATIENT SAMPLES. POSITIVE CONTROL COMPLETED FOR THE ASSAY WAS POSITIVE.

    Description of Event or Problem · 1

    FALSE POSITIVE: CUSTOMER REPORTED FALSE POSITIVE RESULT WITH SOLANA SARS. NEGATIVE SARS BUT POSITIVE ADENOVIRUS ON BIOFIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589604 QUIDEL SOLANA SARS-COV-2 ASSAY (M313) SOLANA SARS-COV-2 ASSAY QJR QUIDEL CORPORATION Coronavirus 188141 30014613339656

    Patients

    Seq Age Sex Outcome Treatment
    1