BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIAISON SARS-COV-2 S1/S2 IGG

    MDR report key: 11988982 · Received June 13, 2021

    Report

    Report Number
    9610240-2021-00034
    Event Type
    Malfunction
    Date Received
    June 13, 2021
    Report Date
    June 11, 2021
    Manufacturer
    DIASORIN S.P.A.
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN (B)(4) RECEIVED A COMPLAINT FROM A CUSTOMER STATING THAT NEGATIVE RESULTS WERE OBTAINED WITH THE LIAISON SARS-COV-2 S1/S2 IGG ASSAY FOR PCR POSITIVE SAMPLES. SAMPLES ALSO RESULTED AS POSITIVE WITH COMPETITOR SEROLOGY ASSAYS. IN TOTAL, 22 PCR POSITIVE SAMPLES WERE TESTED: 13 RESULTED AS POSITIVE AND 9 AS NEGATIVE WITH DIASORIN ASSAY; THESE 9 SAMPLES WERE POSITIVE WITH OTHER SEROLOGY ASSAYS. CUSTOMER ALSO PERFORMED A LIMITED METHOD COMPARISON WITH 10 POSITIVE AND 10 NEGATIVE SAMPLES PREVIOUSLY RUN ON THE ABBOTT ARCHITECT ASSAY. ALL 10 NEGATIVE SAMPLES AGREED AND 9 OUT OF 10 POSITIVE SAMPLES AGREED (ONE SAMPLE GAVE AN INDEX OF 13 ON THE LIAISON XL, RESULTING AS NEGATIVE). ON (B)(6) 2020, 587 PATIENT SAMPLES WERE TESTED WITH THE DIASORIN ASSAY. FOR 161 OF THESE SAMPLES, PCR RESULTS WERE PREVIOUSLY OBTAINED: 22 WERE PCR POSITIVE AND 139 PCR NEGATIVE. AMONG THE 22 PCR SAMPLES, FOUR RESULTED AS NEGATIVE WITH DIASORIN ASSAY. SEROLOGY TEST WAS PERFORMED 17 DAYS AFTER PCR FOR SAMPLE 1 (INDEX: 4.0), 1 DAY AFTER PCR FOR SAMPLE 2 (INDEX: <3.80), 37 DAYS AFTER PCR FOR SAMPLE 3 (INDEX: 7.5) AND 20 DAYS AFTER PCR FOR SAMPLE 4 (INDEX <3.80). CUSTOMER CONSIDERED SAMPLE 2 AS IRRELEVANT, THEREFORE 3 OF THE 22 SAMPLES WERE CONSIDERED AS FALSE NEGATIVE (13%). IT WAS REMINDED THAT ABBOTT ASSAY IS DESIGNED TO DETECT IGG ANTIBODIES TO THE NUCLEOCAPSID PROTEIN OF SARS-COV-2, WHEREAS THE LIAISON SARS-COV-2 S1/S2 IGG ASSAY IS DESIGNED TO DETECT THE RECOMBINANT S1 AND S2 ANTIGENS OF COVS AND ARE PRODUCED IN ABUNDANT QUANTITIES DURING ACUTE INFECTION. ACCORDING TO LAST LITERATURE DATA, LEVELS OF NABS IN PATIENTS WERE VARIABLE AND ABOUT 30% OF PATIENTS FAILED TO DEVELOP HIGH TITERS OF NABS AFTER COVID-19 INFECTION. HOWEVER, THE DISEASE DURATION OF THESE PATIENTS COMPARED TO OTHERS WAS SIMILAR. NOTABLY, THERE WERE TEN RECOVERED PATIENTS WHOSE NAB TITERS WERE VERY LOW. THE COMPLAINT WAS CLASSIFIED AS NOT CONFIRMABLE. NO CLEAR ROOT CAUSE COULD BE IDENTIFIED: THE ISSUE COULD BE RELATED TO THE SPECIFIC SAMPLE OR TO SAMPLE HANDLING AND STORAGE. CLAIMED PRODUCT PERFORMANCES OF THE INVOLVED KIT, REPORTED ON IFU, WERE MAINTAINED. AS REPORTED IN THE IFU, THE LIAISON SARS-COV-2 S1/S2 IGG ASSAY AND ITS CLINICAL PERFORMANCE WERE BASED ON CLINICAL SENSITIVITY DEFINED BY PCR POSITIVE; NO COMPARISON STUDIES WITH OTHER SEROLOGICAL TESTS ARE AVAILABLE AND DIFFERENCES WITH COMPETITORS' ASSAYS MAY BE EXPECTED AND CANNOT BE RELATED TO PRODUCT DEFICIENCIES.

    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 (B)(4) RECEIVED A COMPLAINT FROM A CUSTOMER STATING THAT NEGATIVE RESULTS WERE OBTAINED WITH THE LIAISON SARS-COV-2 S1/S2 IGG ASSAY FOR SAMPLES GRADED AS POSITIVE WITH PCR AND OTHER SEROLOGY ASSAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885819 LIAISON SARS-COV-2 S1/S2 IGG QUALITATIVE DETECTION OF IGG ANTIBODIES TO SARS-COV-2 QKO DIASORIN S.P.A. 358003

    Patients

    Seq Age Sex Outcome Treatment
    1