BEUDAMED
    FDA Adverse Event Other Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HIV 1+2 REAGENT PACK

    MDR report key: 1448908 · Received August 6, 2009

    Report

    Report Number
    9680658-2008-00229
    Event Type
    Other
    Date Received
    August 6, 2009
    Date of Event
    July 9, 2009
    Report Date
    July 11, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT DETERMINED THAT QUALITY CONTROL WAS ACCEPTABLE ON THE DAY OF THE EVENT. ANALYSIS OF INSTRUMENT DATALOGGER FILES FOUND NO EVIDENCE TO SUGGEST THE RESULTS IN QUESTION WERE CAUSED BY AN ANALYZER OR REAGENT MALFUNCTION. THE CUSTOMER INDICATES THAT THE REPEATABLE POSITIVE RESULT WAS REPORTED OUTSIDE OF LAB PROCEDURE. THE LAB FOLLOWS THE MFR'S RECOMMENDATION IN THE INSTRUCTIONS FOR USE FOR VITROS ANTI-HIV 1 + 2 WHICH STATE" "ANY RESULT LABELED WITH "REACTIVE" REQUIRES SUPPLEMENTAL TESTING". NO SAMPLE REMAINS FOR FURTHER TESTING. THE ROOT CAUSE FOR THE FALSE POSITIVE ANTI-HIV RESULT IS UNK, HOWEVER, USER ERROR WAS THE CAUSE OF THE ANTI-HIV RESULT BEING REPORTED TO THE CLINICIAN WHO ORDERED THE PTS' TREATMENT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A FALSE POSITIVE ANTI-HIV (VITROS AHIV 1 + 2 ASSAY) RESULT FOR A SINGLE PT SAMPLE PROCESSED ON A VITROS ECIQ SYSTEM. THE RESULTS DID NOT AGREE WITH NEGATIVE RESULTS (METHOD UNK) OBTAINED ON THE SAME SAMPLE AT A REFERENCE LAB. THE FALSE POSITIVE RESULT WAS REPORTED AND THE PT WAS TREATED. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THE TREATMENT GIVEN. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HIV 1+2 REAGENT PACK IN-VITRO DIAGNOSTIC MZF ORTHO-CLINICAL DIAGNOSTICS NA 0210

    Patients

    Seq Age Sex Outcome Treatment
    1