BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIAISON SARS-COV-2 S1/S2 IGG

    MDR report key: 11997291 · Received June 15, 2021

    Report

    Report Number
    9610240-2021-00009
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    September 28, 2020
    Report Date
    June 2, 2021
    Manufacturer
    DIASORIN S.P.A.
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN (B)(4) RECEIVED A COMPLAINT FROM A CUSTOMER REQUESTING WHAT MAY CAUSE STRONG FALSE POSITIVE REACTIONS (~300-400 AU) CONSISTENTLY, OTHER THAN CROSS-REACTIVITY FROM PRE-EXISTING ANTIBODIES. CUSTOMER STATED THAT A TESTED PATIENT RESULTED CONSISTENTLY STRONG POSITIVE FOR FEW MONTHS. THIS PATIENT WAS A HYPERTENSION PRE-KIDNEY TRANSPLANT PATIENT THAT HAS BEEN TESTED REGULARLY FOR 4-5 MONTHS AND WAS CONSISTENTLY RESULTING AT VALUES OF >400AU. THE CUSTOMER ASSESSED THE PATIENT BY AN AUTOIMMUNE PANEL AND NO ANOMALIES WERE HIGHLIGHTED. THE PATIENT WAS PART OF A HISTORY AND POPULATION STUDY AND A 2-YEAR OLD SAMPLE RESULTED AT > 400AU ON DIASORIN ASSAY. DATA OBTAINED BY THE CUSTOMER SHOWED THAT SAMPLE WAS GRADED NEGATIVE WITH BOTH ABBOTT AND EUROIMMUN ASSAYS AND THAT LOW DOSES WERE RECEIVED FROM TESTING. THE SAMPLE WAS TESTED ON LIAISON XL S/N 2210003174 ON 28TH SEPTEMBER 2020 AND RESULTED HIGH POSITIVE WITH THE LIAISON SARS-COV-2 S1/S2 IGG ASSAY. DIASORIN CONTROLS WERE TESTED AND FELL WITHIN COA RANGES. PERFORMANCE LOOKED ADEQUATE ON CONTROLS BASED ON THE DATA PROVIDED. THE CUSTOMER USED THE LIAISON SARS-COV-2 S1/S2 IGG LOT 358010. BASED ON DATA OBTAINED IN-HOUSE AT BATCH RELEASE, 500 BLOOD DONOR SAMPLES WERE TESTED AND THE FOLLOWING RESULTS WERE OBTAINED FOR KIT LOT 358010: 99.8%. THEREFORE, THE INTERNAL TESTING DEMONSTRATED THAT KIT LOT 358010 MET SPECIFICATIONS (IFU CLAIM FOR NEGATIVE PERCENT AGREEMENT: 99.3% WITH A 95% CI OF 98.6-99.6%). BASED ON THE INFORMATION PROVIDED, THE COMPLAINT WAS CLASSIFIED AS CONFIRMED DUE TO THE OCCURRENCE OF THE EVENT. THE INVESTIGATION CONCLUSION REPORTED THAT NO CLEAR ROOT CAUSE COULD BE IDENTIFIED: PROBABLE CAUSES ARE MOST LIKELY TO BE INSTRUMENT- OR HANDLING-RELATED. PERFORMANCES OF LIAISON® SARS-COV-2 S1/S2 IGG KIT (REF 311460) WAS VERIFIED AND CONFIRMED TO BE COHERENT WITH THE CLAIMED ONE. BASED ON THE AVAILABLE INFORMATION, THE ISSUE EXPERIENCED BY THE CUSTOMER COULD BE SAMPLE-RELATED. NO FURTHER INFORMATION ARE AVAILABLE IN ADDITION TO THE ONE REPORTED IN THE IFUS (CHAPTER 14) ABOUT POSSIBLE INTERFERING SUBSTANCES AND/OR ASPECTS WHICH MAY LEAD TO INACCURATE RESULTS. RELEASE BATCH SHEET AND NC DATA BASE 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 (B)(4) RECEIVED A COMPLAINT FROM A CUSTOMER STATING THAT A TESTED PATIENT RESULTED CONSISTENTLY STRONG POSITIVE FOR FEW MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902628 LIAISON SARS-COV-2 S1/S2 IGG QUALITATIVE DETECTION OF IGG ANTIBODIES TO SARS-COV-2 QKO DIASORIN S.P.A. 358010

    Patients

    Seq Age Sex Outcome Treatment
    1