BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIDEL SOLANA SARS-COV-2 ASSAY (M313)

    MDR report key: 11698402 · Received April 20, 2021

    Report

    Report Number
    1000122536-2021-00029
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    February 15, 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
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATIONAL SUMMARY: REVIEW OF CUSTOMER DATA SHOWS THAT SOME SAMPLES YIELD POSITIVE RESULTS DURING ONE RUN AND THEN NEGATIVE RESULTS (OR VICE VERSA) ON REPEAT TESTING. (B)(4). RETAIN TESTING SHOWS THAT THE PRODUCT PERFORMS AS EXPECTED. QC WAS UNABLE TO DUPLICATE CUSTOMER'S COMPLAINT.

    Description of Event or Problem · 1

    FALSE POSITIVE: CUSTOMER REPORTED 5X FALSE POSITIVE FOR SOLANA SARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590780 QUIDEL SOLANA SARS-COV-2 ASSAY (M313) SOLANA SARS-COV-2 ASSAY QJR QUIDEL CORPORATION Coronavirus 30014613339656

    Patients

    Seq Age Sex Outcome Treatment
    1