BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIAISON SARS-COV-2 IGM

    MDR report key: 11841732 · Received May 18, 2021

    Report

    Report Number
    9610240-2021-00001
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    January 21, 2021
    Report Date
    May 18, 2021
    Manufacturer
    DIASORIN S.P.A.
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN'S LOCAL DISTRIBUTOR IN (B)(4) INFORMED DIASORIN THAT, IN THE FRAME OF A LOCAL EVALUATION TO VALIDATE THE LIAISON SARS-COV-2 IGM ASSAY, UNSATISFACTORY SPECIFICITY RESULTS WERE OBTAINED. DATA SHOWED THAT OUT OF 100 EXPECTED NEGATIVE SPECIMENS, 4 WERE POSITIVE WITH THE LIAISON SARS-COV-2 IGM ASSAY. PCR AND/OR THIRD METHOD TO CONFIRM DISCORDANT SAMPLES WAS NOT PERFORMED AS THE SAMPLES WERE PART OF A PRE-SELECTED PANEL. INSTRUMENT DATA WAS ANALYSED: EVALUATION WAS PERFORMED ON 29TH JANUARY 2021 BY USING THE LIAISON SARS-COV-2 IGM LOT 360008. DIASORIN CONTROLS WERE TESTED ON 29TH JANUARY 2021 AND FELL WITHIN COA RANGES. KIT CALIBRATION WAS RUN ON 29TH JANUARY 2021 AS WELL, HOWEVER IT WAS FLAGGED WITH "SHORT INTEGRAL AGITATION TIME" MESSAGES. DIASORIN NOTICED THAT IN THE ANALYSED PERIOD MAINTENANCE TASKS APPEARED AS NOT ALWAYS PERFORMED ACCORDING TO PROCEDURE. SAMPLES WERE STORED FROZEN IN SECONDARY TUBES (<2 FREEZE THAW CYCLES; STORAGE ON DAY OF ANALYSIS WAS 2-8 °C; SPECIMENS WERE CENTRIFUGED AT 3000G PRIOR TO ANALYSIS). BASED ON THE INFORMATION RECEIVED, THE ELISA ASSAY USED TO CHARACTERIZE THE NEGATIVE PANEL HAS THE N PROTEIN AS TARGET ANTIGEN. THE LIAISON SARS-COV-2 IGM ASSAY INSTEAD USES MAGNETIC PARTICLES COATED WITH S1-RBD ANTIGEN AS TARGET FOR ANTIBODIES DETECTION. SOME VARIATIONS CAN BE EXPECTED USING TESTS FOR ANTIBODIES DETECTION SINCE DIFFERENT ANTIBODIES FAMILIES ARE PRESENT DEPENDING ON THE PATIENT AND LEVEL ANTIBODIES TITRE CAN BE DETECTED IN DIFFERENT WAYS BY DIVERSE ASSAYS USING UNIQUE SOLID PHASES, ANTIGEN PREPARATION AND/OR CONCENTRATION. BASED ON THE INFORMATION RETRIEVED, THE COMPLAINT HAS BEEN CLASSIFIED AS NOT CONFIRMABLE. AT THE RELEASE OF THE LIAISON SARS-COV-2 IGM LOT 360008 DIASORIN TESTED A PANEL OF 30 EXPECTED NEGATIVE SPECIMENS COLLECTED PRE-COVID 19 PANDEMIC IN ORDER TO ASSESS THE PERFORMANCE OF THE ASSAY: ALL SAMPLES WERE GRADED AS EXPECTED CONFIRMING THE ADEQUACY OF LOT 360008 PERFORMANCE. NO CLEAR ROOT CAUSE COULD BE IDENTIFIED, HOWEVER THE ISSUE COULD BE SAMPLE-RELATED AND/OR RELATED TO SUBOPTIMAL INSTRUMENT MAINTENANCE.

    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 SPA RECEIVED A COMPLAINT FROM A DISTRIBUTOR WHO PERFORMED A LOCAL EVALUATION TO VALIDATE THE LIAISON SARS-COV-2 IGM ASSAY AND OBTAINED UNSATISFACTORY RESULTS FOR SPECIFICITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742544 LIAISON SARS-COV-2 IGM SEROLOGICAL ASSAY FOR QUALITATIVE DETECTION OF IGM ANTIBODIES TO SARS-COV-2 QKO DIASORIN S.P.A. 360008

    Patients

    Seq Age Sex Outcome Treatment
    1