BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIASORIN ETI-MAK-2 PLUS ASSAY

    MDR report key: 1641119 · Received March 17, 2010

    Report

    Report Number
    9610240-2010-00002
    Event Type
    Other
    Date Received
    March 17, 2010
    Report Date
    February 26, 2010
    Manufacturer
    DIASORIN S.P.A.
    Product Code
    LOM
    PMA / PMN Number
    P990038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO RECEIVED FROM THE CUSTOMER THE PT HAS A HISTORY OF HAVING CHRONIC (B)(6) INFECTION. PT HAS PREVIOUSLY TESTED POSITIVE FOR (B)(6) WITH ANOTHER MFR'S ASSAY AS WELL AS PCR (B)(6) DNA. A RECENT TESTING FOR (B)(6) DNA WAS NEGATIVE. THE DIFFERENCE HIGHLIGHTED BY THE TWO SYSTEMS CAN BE EASILY EXPLAINED BY THE ANALYTICAL SENSITIVITY CLAIMS REPORTED IN THE RESPECTIVE INSTRUCTIONS FOR USE: DIASORIN ETI-MAK-2 = 0.1 AD + AY PEI (B)(6) U/ML. ADVIA CENTAUR = 0.034 AD PEI U/ML AND 0.033 AY PEI U/ML. THE PERFORMANCE OF ETI-MAK-2 PLUS LOT# 0710240A IN TERMS OF SENSITIVITY HAVE BEEN VERIFIED AND CONFIRMED TO BE ALIGNED WITH THE PUBLISHED CLAIM AS STATED IN THE INSTRUCTIONS FOR USE. THE ALGORITHM AS RECOMMENDED BY THE CDC ALWAYS PRESCRIBES FOR DIAGNOSTIC PURPOSES THE TESTING OF DIFFERENT (B)(6) MARKERS, AMONG WHICH (B)(6) IS ONLY ONE. THE INSTRUCTIONS FOR USE ACCOMPANYING BOTH KITS STATE THE RESULTS SHOULD NOT BE USED ALONE BUT IN CONJUNCTION WITH THE PT'S CLINICAL PRESENTATION AND OTHER (B)(6) MARKER RESULTS FOR THE CORRECT DETERMINATION OF (B)(6) INFECTIOUS STATUS. IN THE INSTRUCTIONS FOR USE ACCOMPANYING THE ADVIA CENTAUR AND DIASORIN ETI-MAK-2 PLUS ASSAYS THE (B)(6) MARKER PATTERNS OBSERVED DURING CLINICAL VALIDATION OF EACH PRODUCT ARE REPORTED. BASED ON THE REPORTED DATA, THE MOST PROBABLE CLASSIFICATION FOR THIS PT SPECIMEN UNDER INVESTIGATION IS EITHER CHRONIC (IF (B)(6) IS SCORED POSITIVE AND PRESENT FOR AT LEAST SIX MONTHS) OR EARLY RECOVERY (IF (B)(6) IS SCORED NEGATIVE). BASED ON THE (B)(6) MARKER PATTERNS REPORTED IN THE LITERATURE, AN ACUTE INFECTION CAN BE EXCLUDED DUE TO THE ABSENCE OF IGM (B)(6) AND SUBSEQUENT NEGATIVE (B)(6) DNA RESULT. AS AN OUTCOME OF THE ABOVE ANALYSIS, THE CONSEQUENT RISK LINKED TO THE FAILURE TO DETECT THE (B)(6) PRESENCE IS VERY LIMITED FOR THE HERE BELOW LISTED CONSIDERATIONS. TAKING INTO ACCOUNT THE (B)(6) MARKERS FOR THIS SPECIFIC SAMPLE AND THE RELATED CLINICAL STATUS, PT MGMT WAS NOT AFFECTED. IN BOTH CASES ((B)(6) EITHER POSITIVE OR NEGATIVE) THE EXPECTED CONSEQUENCE FROM A CLINICAL POINT OF VIEW IS THE NEED TO OBTAIN AN ADDITIONAL PT SAMPLE IN ORDER TO DO F/U TESTING OF OTHER (B)(6) MARKERS. THIS MONITORING SHOULD ALLOW A MORE ACCURATE (B)(6) INFECTIOUS STATUS DETERMINATION AND THE ABILITY TO ASSESS WHEN THE PT IS TRULY RECOVERING WITH THE APPEARANCE OF (B)(6) ANTIBODIES.

    Description of Event or Problem · 1

    A CUSTOMER, SPECTRA EAST INC REPORTED A DISCORDANT RESULT BETWEEN THE DIASORIN ETI-MAK-2 PLUS ASSAY AND ADVIA CENTAUR (B)(6). THE PT SAMPLE WAS REPEATEDLY REACTIVE BY ADVIA CENTAUR INCLUDING THE CONFIRMATORY TEST. SUBSEQUENT TESTING ON THE ETI-MAK-2 PLUS KIT WAS NON-REACTIVE. THE CUSTOMER REPORTED THE NON-REACTIVE RESULT WHICH WAS QUESTIONED BY THE CLINICIAN BECAUSE THE PT WAS KNOWN TO BE CHRONICALLY INFECTED WITH (B)(6). (B)(6) MARKERS WERE RUN ON ADVIA CENTAUR, TEST DATE (B)(6) 2010. SAMPLE WAS SENT OUT FOR BDNA TESTING, DATE UNK. BDNA - NEGATIVE. SAMPLE WAS ALSO FOUND TO BE (B)(6) AND (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIASORIN ETI-MAK-2 PLUS ASSAY LOM TEST, HEPATITIS B LOM DIASORIN S.P.A. 0710240A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other