BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIAISON SARS-COV-2-AG

    MDR report key: 19673984 · Received July 4, 2024

    Report

    Report Number
    9610240-2024-00004
    Event Type
    Malfunction
    Date Received
    July 4, 2024
    Date of Event
    June 12, 2024
    Report Date
    July 4, 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

    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 RELATED 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 SPECIFICITY 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 THE 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 NOTIFICATION), 371032 AND 371036. PERFORMANCE OBTAINED BY KIT LOT WAS AS FOLLOWS: LOT; NEG; POS; POTENTIAL; FP; SPEC; EXACT 95% CI: 371032, 4489, 589, 13, 99.7%, 99.5%, 99.8%; 371033, 6848, 1028, 63, 99.1%, 98.8%, 99.3%; 371036, 457, 24, 2, 99.6%, 98.4%, 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572123 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