BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR HIV 1/O/2 ENHANCED ASSAY

    MDR report key: 1221828 · Received November 4, 2008

    Report

    Report Number
    1219913-2008-00089
    Event Type
    Other
    Date Received
    November 4, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 29, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MVW
    PMA / PMN Number
    P050030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUCTION FOR USE CLEARLY STATES THAT REPEATEDLY REACTIVE SPECIMENS ON THE ADVIA CENTAUR MUST BE INVESTIGATED USING SUPPLEMENTAL TESTS. THIS EVENT IS BEING REPORTED BECAUSE THE LAB TECH WAS ADMINISTERED TREATMENT BASED ON THE REACTIVE RESULTS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A LABORATORY TECHNICIAN ACCIDENTALLY STUCK HERSELF WITH A NEEDLE. A BLOOD SAMPLE FROM THIS TECHNICIAN WAS TESTED FOR USING THE ADVIA CENTAUR HIV 1/O/2 ENHANCED ASSAY. THE INITIAL AND REPEAT RESULTS WERE BOTH REACTIVE. SUPPLEMENTAL CONFIRMATORY TESTING WAS PERFORMED AND THE RESULTS WERE NON-REACTIVE. A NEW BLOOD SAMPLE WAS DRAWN FROM THE LAB TECHNICIAN AND THE ADVIA CENTAUR 1/O/2 ENHANCED ASSAY RESULT WAS REACTIVE WHEREAS THE CONFIRMATORY RESULT WAS NON-REACTIVE. THE LABORATORY TECHNICIAN WAS ADMINISTERED GAMMA GLOBULIN AND COMBOVERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR HIV 1/O/2 ENHANCED ASSAY EHIV IMMUNOASSAY MVW SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 141

    Patients

    Seq Age Sex Outcome Treatment
    1