BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIAISON SARS COV-2 AG

    MDR report key: 15295572 · Received August 25, 2022

    Report

    Report Number
    9610240-2022-00001
    Event Type
    Malfunction
    Date Received
    August 25, 2022
    Date of Event
    July 23, 2022
    Report Date
    August 19, 2022
    Manufacturer
    DIASORIN S.P.A.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER EMAILED TECHNICAL SUPPORT ON (B)(6) 2022 STATING ONE SAMPLE IS SUSPECTING FALSE POSITIVE RESULTS REGARDING COV-2 ANTIGEN(REF:(B)(4) LOT: 373027). INSTRUMENT MAINTENANCE HAS BEEN PERFORMED ACCORDINGLY TO INSTRUCION. THE SAMPLE WAS RETESTED THE SAME DAY AND GRADED NEGATIVE. THE LIAISON® SARS-COV-2 AG ASSAY USES CHEMILUMINESCENCE IMMUNOASSAY (CLIA) TECHNOLOGY FOR THE QUALITATIVE DETERMINATION OF SARS-COV-2 NUCLEOCAPSID PROTEIN ANTIGEN IN NASOPHARYNGEAL SWAB (NPS) COLLECTED IN COPAN UNIVERSAL TRANSPORT MEDIA (UTM) AND DIRECT ANTERIOR NASAL SWAB (NS) WITHOUT TRANSPORT MEDIA, IN INDIVIDUALS SUSPECTED TO HAVE COVID-19 BY THEIR HEALTHCARE PROVIDER WITHIN THE FIRST TEN DAYS FROM THE ONSET OF SYMPTOMS. IT WAS MENTIONED THAT THE PATIENT WAS NOT SYMPTOMATIC. AS PER IFUS THE PERFORMANCE OF THIS TEST HAS NOT BEEN EVALUATED FOR USE IN PATIENTS WITHOUT SIGNS AND SYMPTOMS OF RESPIRATORY INFECTION. ALL INFORMATION RELATED TO THE BATCH CONFORM THAT THE BATCH PERFORMS AS EXPECTED   COMPLAINT ANALYSIS IS STILL ON GOING, CURRENTLY NO CLEAR ROOT CAUSE COULD BE IDENTIFIED

    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 S.P.A. RECEIVED A COMPLAINT ABOUT INCREASE OF FALSE POSITIVE RESULTS OF COV-2 ANTIGENS (REF: (B)(4) LOT: 373027).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2393394 LIAISON SARS COV-2 AG SARS-COV-2 ANTIGEN DETECTION TEST SYSTEM. QKP DIASORIN S.P.A. 373027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown