BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIDEL SOLANA SARS-COV-2 ASSAY (M313)

    MDR report key: 11698415 · Received April 20, 2021

    Report

    Report Number
    1000122536-2021-00035
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    February 25, 2021
    Report Date
    April 20, 2021
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QJR
    PMA / PMN Number
    EUA203087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATIONAL SUMMARY: RETAIN TESTING YIELDED EXPECTED RESULTS. NO FALSE POSITIVES WERE OBSERVED IN EITHER THE NEGATIVE CONTROL OR NEGATIVE UTM SAMPLES TESTED. UNABLE TO DUPLICATE CUSTOMER COMPLAINT. UNABLE TO DETERMINE ROOT CAUSE.

    Description of Event or Problem · 1

    FALSE POSITIVE: CUSTOMER REPORTED FALSE POSITIVE RESULTS ON SOLANA SARS ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589606 QUIDEL SOLANA SARS-COV-2 ASSAY (M313) SOLANA SARS-COV-2 ASSAY QJR QUIDEL CORPORATION 111120

    Patients

    Seq Age Sex Outcome Treatment
    1