BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIAISON® XL MUREX HCV AB

    MDR report key: 16156437 · Received January 13, 2023

    Report

    Report Number
    3008576040-2020-00001
    Event Type
    Malfunction
    Date Received
    January 13, 2023
    Date of Event
    October 29, 2020
    Report Date
    January 13, 2023
    Manufacturer
    DIASORIN S.P.A UK BRANCH
    Product Code
    MZO
    UDI-DI
    08056771500197
    PMA / PMN Number
    P190011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS PROPERLY SENT WITHIN 30 DAYS VIA THE ELECTRONIC SUBMISSION GATEWAY (ESG) BY DIASORIN INC. MN/US AS DISTRIBUTOR AND INCLUDED IN THE FDA MAUDE ADVERSE EVENT REPORT DATABASE. REPORT DATE 11/26/2020. WHILST RECHECKING THE ELECTRONIC GATEWAY SUBMISSION SYSTEM FOR THE 2020 RECORDS OF THE UK MDR ON LIAISON XL MUREX HCV AB (318240), LOT 279017 (EXP. 24/05/2021), THE MANUFACTURER DIASORIN ITALIA S.P.A UK BRANCH DISCOVERED THAT ITS MDR SUBMISSION WAS COMPLETED INCORRECTLY IN THE IN THE TEST ACCOUNT ENVIRONMENT RATHER THAN THE PROPER PRODUCTION ACCOUNT ENVIRONMENT. AFTER RESTORING THE WEBTRADER PRODUCTION ACCOUNT, THIS MANUFACTURER REPORT HAS BEEN SENT NOW. AN INTERNAL NON CONFORMITY HAS BEEN OPENED TO PREVENT THE RECURRENCE OF THIS ISSUE. IN THIS SPECIFIC CASE TESTING WAS DONE ON A PATIENT ON ALREADY KNOWN HCV POSITIVE PATIENT. THEREFORE DIAGNOSIS HAS ALREADY BEEN ESTABLISHED PREVIOUSLY, AND THE ANTI-HCV TESTING ON THE LATEST BLEED OF THIS PATIENT COULD NOT PROVIDE ANY FURTHER DIAGNOSTIC VALUE, SO NO ADVERSE EVENT OCCURRED (I.E. EVENT LEADING TO DEATH OR SERIOUS INJURY / DETERIORATION OF STATE OF HEALTH). A NUCLEIC ACID TESTING PERFORMED WITHIN THE COMPLAINT INVESTIGATION PROVIDED EVIDENCE OF NO VIRAL LOAD (HCV RNA), THEREFORE ALLOWING TO DEFINE THIS CASE AS A PAST INFECTION AND RULE OUT AN ACTIVE HCV INFECTION. IN MORE GENERAL TERMS CONSEQUENCE OF A FALSE NEGATIVE RESULT FOR THE DETECTION OF ANTI-HCV ANTIBODIES ON HCV POSITIVE SUBJECT (I.E. HCV RNA POSITIVE), WHEN SYMPTOMS ARE NOT PRESENT, COULD BE A DELAYED INITIATION OF THE THERAPY AND A LACK OF AWARENESS OF THE PATIENT ABOUT THE CONDITION OF BEING CAPABLE TO SPREAD THE INFECTION. THIS KIND OF CONSEQUENCE CANNOT BE EXCLUDED BY ANY DEVICE FOR THE DETERMINATION OF ANTI-HCV ANTIBODIES, SINCE EVEN WHEN THERE IS A SUBSTANTIAL EQUIVALENCE BETWEEN METHODS, DIFFERENCES MAY BE PRESENT BETWEEN CASES WHEN CONCENTRATION OF ANTI-HCV ANTIBODIES IS CLOSE TO THE DETECTION LIMIT OF THE ASSAYS. FOR THE DIAGNOSIS OF ACUTE OR CHRONIC INFECTION LIAISON XL MUREX HCV AB RESULTS SHOULD BE INTERPRETED IN CONJUNCTION WITH PATIENT'S CLINICAL PICTURE AND OTHER DIAGNOSTIC PROCEDURES. AS REPORTED IN SECTION 12 OF THE INSTRUCTION FOR USE (LIMITATION OF THE PROCEDURE) "DIAGNOSIS OF INFECTIOUS DISEASES SHOULD NOT BE ESTABLISHED ON THE BASIS OF A SINGLE TEST RESULT, BUT SHOULD BE DETERMINED IN CONJUNCTION WITH CLINICAL FINDINGS AND OTHER DIAGNOSTIC PROCEDURES AS WELL AS IN ASSOCIATION WITH MEDICAL JUDGEMENT. A FULL DIFFERENTIAL DIAGNOSTIC WORK-UP FOR THE DIAGNOSIS OF HEPATITIS C AND RELATED CLINICAL CONDITIONS INCLUDES EXAMINATION OF THE PATIENT'S IMMUNE STATUS AND CLINICAL HISTORY." (SOURCE: IFU EN - C0231824GB, 02 - 2019-12). WORKSHEET REFERENCE (B)(4) HAS BEEN OPENED TO DOCUMENT THIS COMPLAINT INVESTIGATION.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINED THAT A PATIENT SAMPLE RESULT WAS NONREACTIVE WITH LIAISON® XL MUREX HCV AB (S/CO = 0.61), BUT REACTIVE (S/CO = 1.17) ON THE LABORATORIES CHEMISTRY ANALYZER (SIEMENS ATELLICA). CUSTOMER IS RUNNING LIAISON® XL MUREX HCV AB AFTER SIEMENS FOR CONFIRMATION OF REACTIVE RESULTS. THE CHEMISTRY DEPARTMENT RAN THE SAMPLE FIRST, WHEN THE RESULT IS REACTIVE, THE SAMPLE IS TESTED ON DIASORIN INSTRUMENT. ALL POSITIVE RESULTS NEED TO BE REPORTED TO THE DEPARTMENT OF HEALTH. WHEN THE CHEMISTRY DEPARTMENT SUPERVISOR REPORTED ONLINE SHE SAW THAT THIS PATIENT HAS A PREVIOUS HISTORY OF POSITIVE HEPATITIS C. PREVIOUS RESULTS FOR THIS PATIENT ARE NOT AVAILABLE, THIS PATIENT SAMPLE WAS RECEIVED FOR THE FIRST TIME IN THIS LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224798 LIAISON® XL MUREX HCV AB IVD ASSAY FOR QUALITATIVE DETERMINATION OF ANTIBODIES TO HCV MZO DIASORIN S.P.A UK BRANCH LIAISON® XL MUREX HCV AB 279017 08056771500197

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown