BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIASORIN ETI-MAK-2 PLUS ASSAY

    MDR report key: 1611012 · Received February 3, 2010

    Report

    Report Number
    9610240-2010-00001
    Event Type
    Other
    Date Received
    February 3, 2010
    Date of Event
    January 19, 2010
    Report Date
    January 22, 2010
    Manufacturer
    DIASORIN S.P.A.
    Product Code
    LOM
    PMA / PMN Number
    P990038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INFO PROVIDED BY THE CUSTOMER SUGGESTS THAT THE NEGATIVE RESULT OBTAINED WITH ETI-MAK-2 IS CONSISTENT WITH THE EVENTUAL CLINICAL DIAGNOSIS OF THE PT, THOUGH SPECIFIC INFO ON PT STATUS IS CONFIDENTIAL. IT IS SUSPECTED THAT THE POSITIVE RESULTS PROVIDED BY THE OTHER TWO TEST METHODS MAY HAVE BEEN THE RESULT OF (B)(6) ANTIGENEMIA DUE TO THE (B)(6) VACCINATION RECEIVED BY THE PT AND NOT AN ACTIVE INFECTION; DIASORIN IS CONDUCTING AN INTERNAL EVALUATION OF ETI-MAK2 REACTIVITY WITH (B)(6) VACCINES TO ASSESS ROOT CAUSE FOR THE DISCORDANT RESULTS.

    Description of Event or Problem · 1

    CUSTOMER (REFERENCE LAB 2) REPORTED DISCORDANT RESULTS BETWEEN DIASORIN ETI-MAK-2 PLUS ASSAY AND TWO OTHER REFERENCE LABS. THE PT SAMPLE INITIALLY TESTED REACTIVE ON SCREEN AND CONFIRMATORY BY ANOTHER METHOD (REFERENCE LAB 1). A SECOND SAMPLE WAS DRAWN FROM THE PT AND TESTED AT THE CUSTOMER SITE USING DIASORIN ETI-MAK-2 PLUS AND WAS NON-REACTIVE. CONSISTENT WITH KIT INSTRUCTIONS FOR USE, NO RETEST OR CONFIRMATORY TESTING WAS PERFORMED BY THE CUSTOMER FOR THIS NEGATIVE RESULT. THE CUSTOMER FORWARDED THE REMAINDER OF THE SAMPLE TO A THIRD REFERENCE LAB (REFERENCE LAB 3) WHICH FOUND THE SAMPLE TO BE REACTIVE USING A THIRD TEST METHOD. NO CONFIRMATORY TEST WAS PERFORMED AT THE THIRD SITE DUE TO INSUFFICIENT SAMPLE VOLUME.

    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 1 MO Other