BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP HBSAG

    MDR report key: 1933425 · Received December 15, 2010

    Report

    Report Number
    1219913-2010-00160
    Event Type
    Other
    Date Received
    December 15, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 30, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE NO KNOWN SYSTEM ISSUES THAT MAY HAVE CONTRIBUTED TO THE DISCORDANT FALSE REACTIVE ADVIA CENTAUR XP (B)(6) TEST RESULTS. THE CUSTOMER DOES NOT REQUIRE A SITE VISIT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSE REACTIVE ADVIA CENTAUR XP (B)(6) RESULTS WERE OBTAINED BY THE CUSTOMER ON A PT SAMPLE AND CONFIRMED REACTIVE WITH CONFIRMATORY TESTING. A REACTED RESULTS WAS REPORTED. THE PT WAS LATER REDRAWN FOR REPEAT (B)(6) TESTING AND THE RESULTS WERE REACTIVE NOT CONFIRMED. A NON REACTIVE TEST RESULT WAS REPORTED. THERE WAS NO KNOWN REPORT OF PT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE CONFIRMED FALSE REACTIVE ADVIA CENTAUR (B)(6) ASSAY TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP HBSAG HBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 151

    Patients

    Seq Age Sex Outcome Treatment
    1