BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIAISON SARS COV-2 AG

    MDR report key: 13116715 · Received December 30, 2021

    Report

    Report Number
    9610240-2021-00043
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    December 7, 2021
    Report Date
    December 28, 2021
    Manufacturer
    DIASORIN S.P.A.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER NOTICED THAT THEY HAD A SAMPLE RESULT AS A FALSE POSITIVE. IT WAS TESTED AGAIN USING PCR AND RESULTED NEGATIVE. NO OTHER FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Description of Event or Problem · 0

    IN LIGHT OF THE COVID-19 PANDEMIC AND THE SUBSEQUENT AUTHORIZATIONS (EUAS) FOR SARS-COV-2 DIAGNOSTICS TESTS AND PER THE CONDITIONS OF THE EMERGENCY USE AUTHORIZATION, SUSPECTED FALSE NEGATIVES, FALSE POSITIVES AND SIGNIFICANT CHANGES IN EXPECTED PERFORMANCE CHARACTERISTICS WILL BE REPORTED UNDER 21 CFR 803. THE ALLEGED FALSE TEST RESULTS IN THIS EVENT HAVE NOT CAUSED PATIENT INJURY OR DEATH; HOWEVER, THIS EVENT IS BEING REPORTED CONSERVATIVELY BECAUSE IF THE ALLEGED MALFUNCTION WERE TO RECUR THERE IS A NON-REMOTE POTENTIAL FOR SERIOUS INJURY OR DEATH. DIASORIN S.P.A. RECEIVED A COMPLAINT ABOUT POTENTIAL FALSE POSITIVE RESULTS OF COV-2 ANTIGENS (REF: 311500 LOT: 373024).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021128 LIAISON SARS COV-2 AG SARS-COV-2 ANTIGEN DETECTION TEST SYSTEM. QKP DIASORIN S.P.A. 374024

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown