BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIAISON SARS-COV-2 IGM

    MDR report key: 12139642 · Received July 8, 2021

    Report

    Report Number
    9610240-2021-00041
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Report Date
    July 8, 2021
    Manufacturer
    DIASORIN S.P.A.
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL NOTIFICATION, INVESTIGATION ON GOING.

    Description of Event or Problem · 1

    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 FROM A CUSTOMER REPORTING THAT A PATIENT SAMPLE, WHICH GRADED AS POSITIVE ON THE DIASORIN ASSAY, RESULTED AS NEGATIVE ON CAIPTAIN CLIA PLATFORM ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037043 LIAISON SARS-COV-2 IGM SEROLOGICAL ASSAY FOR QUALITATIVE DETECTION OF IGM ANTOBIDIES TO SARS COVID 2 QKO DIASORIN S.P.A. 360013

    Patients

    Seq Age Sex Outcome Treatment
    1