BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIDEL SOLANA SARS-COV-2 ASSAY (M313)

    MDR report key: 11698425 · Received April 20, 2021

    Report

    Report Number
    1000122536-2021-00024
    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
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATIONAL SUMMARY: CUSTOMER DID NOT PROVIDE LOT NUMBER BUT REPORTED HAVE SUCCESS AFTER COOLING SAMPLE FOR 15 MINUTES. CUSTOMER REPORTED SENDING DATA, HOWEVER, TS DID NOT RECEIVE ANY FILES. NO INVESTIGATION REQUIRED.

    Description of Event or Problem · 1

    FALSE POSITIVE: REPORT OF FALSE POSITIVE RESULTS ON SOLANA SARS WHEN COMPARED TO BIOFIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589676 QUIDEL SOLANA SARS-COV-2 ASSAY (M313) SOLANA SARS-COV-2 ASSAY QJR QUIDEL CORPORATION Coronavirus 188316 30014613339656

    Patients

    Seq Age Sex Outcome Treatment
    1