BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR HIV 1/O/2 ENHANCED ASSAY

    MDR report key: 1121409 · Received August 12, 2008

    Report

    Report Number
    1219913-2008-00062
    Event Type
    Other
    Date Received
    August 12, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 1, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS INC.
    Product Code
    MZF
    PMA / PMN Number
    P050030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENTS SUCH AS THIS ARE COVERED BY OUR PRODUCT LABELING. THE INSTRUCTIONS FOR USE CLEARLY STATE THE FOLLOWING CAUTION STATEMENT: "CAUTION! POTENTIAL BIOHAZARD: SOME COMPONENTS OF THIS PRODUCT CONTAIN HUMAN SOURCE MATERIAL. NO KNOWN TEST METHOD CAN OFFER COMPLETE ASSURANCE THAT PRODUCTS DERIVED FROM HUMAN BLOOD WILL NOT TRANSMIT INFECTIOUS AGENTS. ALL PRODUCTS MANUFACTURED USING HUMAN SOURCE MATERIAL SHOULD BE HANDLED AS POTENTIALLY INFECTIOUS. HANDLE THIS PRODUCT ACCORDING TO ESTABLISHED GOOD LABORATORY PRACTICES AND UNIVERSAL PRECAUTIONS." THIS EVENT IS BEING REPORTED BECAUSE (AS STATED IN OUR BIOHAZARD CAUTION STATEMENT) NO KNOWN TEST METHOD CAN OFFER COMPLETE ASSURANCE THAT PRODUCTS DERIVED FROM HUMAN BLOOD WILL NOT TRANSMIT INFECTIOUS AGENTS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN EMPLOYEE WAS SPLASHED IN THE EYE WITH ENHANCED ASSAY POSITIVE QUALITY CONTROL MATERIAL. THE EMPLOYEE WAS NOT WEARING EYE PROTECTION. AT THIS TIME, NO TREATMENT WAS PERFORMED BUT THE EMPLOYEE DID GO TO A PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR HIV 1/O/2 ENHANCED ASSAY EHIV IMMUNOASSAY MZF SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1