BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIAISON SARS-COV-2 AG

    MDR report key: 19518975 · Received June 12, 2024

    Report

    Report Number
    9610240-2024-00002
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    May 16, 2024
    Report Date
    June 12, 2024
    Manufacturer
    DIASORIN ITALIA S.P.A.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION RECEIVED, THE PATIENT WAS TESTED WITH RT_PCR AND GRADED NEGATIVE. THE SAMPLE ID (B)(6). THE SAMPLE WAS TESTED ON (B)(6) 2024 AND GRADED POSITIVE WITH KIT LOT 371033, THE SAMPLE WAS RETESTED ON THE SAME DAY AND IT WAS GRADED NEGATIVE BY USING THE SAME KIT. DATA ANALYSIS SHOWS THAT CUSTOMER ROUTINE WAS AS FOLLOWS DURING THE PERIOD ANALYSED (FIRST REPLICATE OBTAINED FOR EACH SPECIEM WAS CONSIDERED): LOT 371033, NEG 1293, POS 96, TOT 1389. LOT 371036, NEG144, POS1 1, TOT 155. BE INFORMED THAT IF WE CALCULATE THE NEGATIVE PERCENT AGREEMENT (SPECIFICITY) OBTAINED BY THE CUSTOMER WITH KIT LOT 371033 DURING THE PERIOD ANALYSED (BY CONSIDERING THE COMPLAINED SAMPLE AS FP), PERFORMANCE OF THE ASSAY IS ALIGNED TO IFU CLAIMS. CUSTOMER LABORATORY: 99.9 % IFUS CLAIMS 99.7%, 95% CI: 98.1 - 99.9% NO SIGNIFICANT DIFFERENCE BETWEEN THE TWO TESTED POPULATIONS. BASED ON THE GATHERED INFORMATION THE WO HAS BEEN CLASSIFIED AS CONFIRMED, HOWEVER PLEASE CONSIDER THAT THE ASSAY PERFORMANCE IS ALIGNED TO IFU CLAIMS. NO CLEAR ROOT CAUSE IDENTIFIED, THE ISSUE MAY BE SAMPLE-RELATED AND/OR RELATED TO SUBOPTIMAL INSTRUEMNT MAINTENACE. AFTER RECEIVAL OF OTHER NOTIFICATION FROM THE SAME CUSTOMER ((B)(4) ALREADY SUBMITTED TO ESG FDA PORTAL) THE ANALYSIS WAS UPADTED WITH THE FOLLOWING ADDITIONAL DATA: INSTRUMENTAL DATA OF THE INSTRUMENTS INSTALLED AT THE CUSTOMER FACILITY, FROM DECEMBER 2022 TO JUNE 2024, WERE ANALYSED: - MAINTENANCE TASKS ON THE CUSTOMER INSTRUMENTS WERE NOT ALWAYS PERFORMED AS PRESCRIBED: SEVERAL DELAYS WERE REGISTERED IN THE EXECUTION OF THE WEEKLY AND MONTHLY MAINTENANCE TASKS DURING THE PERIOD ANALYSED - DIASORIN CONTROLS WERE NOT RUN ON ALL ROUTINE DAYS. - SEVERAL ERRORS RELEATED TO "SHORT INTEGRAL AGITATION TIME" WERE REGISTERED IN THE LOG FILES - CUSTOMER HAPPENED TO USE REAGENT HAVING REAGENT ON BOARD STABILITY EXPIRED BASED ON THE INFORMATION RECEIVED, CUSTOMER IS USING THE ASSAY TO TEST SPECIMENS COLLECTED WITH DRY NASAL SWAB AND HAPPEN TO USE THE ASSAY TO TEST ASYMPTOMATIC PATIENTS (OUT OF PRODUCT IFUS INTENDED USE) DESPITE THESE EVIDENCE OF DEVIATIONS FROM THE INSTRUCTIONS, BE INFORMED THAT WE CALCULATED THE SPECIFICTY OBTAINED AT THE CUSTOMER SITE. WE CONSIDERED THE FIRST RESULT OBTAINED FOR EACH SPECIMEN TESTED DURING THE PERIOD ANALYSED REGARDLESS OF ANY OF THE DEVIATIONS REPORTED ABOVE. WE COULD IDENTIFY 78 OUT OF THE 87 SAMPLE IDS PROVIDED BY THE CUSTOMER IN TEH AVAILABLE DATA. ALL SAMPLES WERE NEGATIVE WITH RT-PCR BASED ON THE INFORMATION RECEIVED (WORK ORDER, WO, DETAILS CHANGED ACCORDINGLY). THE COMPLAINED SAMPLES WERE TESTED WITH THE LIAISON SARS-COV2-AG LOTS 371033 (OBJECT OF THIS NOTIIFCATION), 371032 AND 371036 . PERFORMANCE OBTAINED BY KIT LOT WAS AS FOLLOWS: LOT 371032, NEG 4489, POS 589, POTENTIAL 13, FP 99.7%, SPEC 99.5%, EXACT 95% CI 99.8%. LOT 371033, NEG 6848, POS 1028, POTENTIAL 63, FP 99.1%, SPEC 98.8% EXACT 95% CI 99.3%. LOT 371036, NEG 457, POS 24, POTENTIAL 2 FP 99.6%, SPEC 98.4%, EXACT 95% CI 99.9%. DATA ANALYSIS SHOWS THAT RESULT OBTAINED HAD NO SIGNIFICANT DIFFERENCE IF COMPARED TO THE RESULTS REPORTED IN THE IFUS.

    Description of Event or Problem · 0

    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 ITALIA S.P.A. RECEIVED A COMPLAINT ABOUT POTENTIAL FALSE POSITIVE RESULT OF COV-2 ANTIGEN (REF: 311490 LOT 371033).

    Description of Event or Problem · 0

    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 ITALIA S.P.A. RECEIVED A COMPLAINT ABOUT POTENTIAL FALSE POSITIVE RESULT OF COV-2 ANTIGEN (REF: 311490 LOT 371033).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152873 LIAISON SARS-COV-2 AG SARS-COV-2 ANTIGEN DETECTION TEST SYSTEM QKP DIASORIN ITALIA S.P.A. 371033

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown