BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIAISON SARS-COV-2 S1/S2 IGG

    MDR report key: 11928988 · Received June 3, 2021

    Report

    Report Number
    9610240-2021-00003
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    June 23, 2020
    Report Date
    June 1, 2021
    Manufacturer
    DIASORIN S.P.A.
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN (B)(4) RECEIVED A COMPLAINT FROM A CUSTOMER STATING THAT FALSE POSITIVE RESULTS WERE OBTAINED WITH THE LIAISON SARS-COV-2 S1/S2 IGG ASSAY. EIGHT (8) SAMPLES RESULTED NEGATIVE WITH THE ROCHE E411 SEROLOGY ASSAY, THE SIEMENS CENTAUR SEROLOGY ASSAY AND THE SD BIOSENSOR LATERAL FLOW POC SEROLOGY ASSAY, BUT POSITIVE WITH THE DIASORIN ASSAY. NONE OF THE PATIENTS HAD ANY KIND OF COMPELLING HISTORY THAT WOULD LEAD THE CUSTOMER TO BELIEVE THEY MIGHT HAVE BEEN POSITIVE FOR COVID-19. CONSIDERING CUSTOMER RESULTS, SPECIFICITY RESULTED (B)(4)). DATA ANALYSIS AND PROPORTION TEST WERE PERFORMED COMPARING CUSTOMER DATA AND ASSAY PERFORMANCE REPORTED IN THE IFU: THERE WERE NO STATISTICAL SIGNIFICANT DIFFERENCES IN DATA OBTAINED AT THE CUSTOMER SITE AND THE DATA REPORTED IN THE IFU. SPECIFICITY PERFORMANCE AT CUSTOMER SITE WAS EVEN HIGHER THAN THE SPECIFICITY REPORTED IN THE IFU. THE COMPLAINT WAS CLASSIFIED AS CONFIRMED DUE TO THE OCCURRENCE OF THE EVENT. NO CLEAR ROOT CAUSE COULD BE IDENTIFIED AND THERE WAS NO EVIDENCE OF ANY PERFORMANCE DEFICIENCY WITH THE INVOLVED KIT LOT. PROBABLE CAUSES ARE MOST LIKELY TO BE INSTRUMENT- OR HANDLING-RELATED. PERFORMANCE OF LIAISON SARS-COV-2 S1/S2 IGG KIT WAS VERIFIED AND CONFIRMED TO BE COHERENT WITH THE CLAIMED ONE. RELEASE BATCH SHEET AND NC DATABASE WERE REVIEWED WITHOUT HIGHLIGHTING ANOMALIES.

    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 STATING THAT FALSE POSITIVE RESULTS WERE OBTAINED ON THE LIAISON SARS-COV-2 S1/S2 IGG ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831861 LIAISON SARS-COV-2 S1/S2 IGG QUALITATIVE DETECTION OF IGG ANTIBODIES TO SARS-COV-2 QKO DIASORIN S.P.A. 358007

    Patients

    Seq Age Sex Outcome Treatment
    1