BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCURUN 1 MULTI-MARKER POSITIVE CONTROL

    MDR report key: 707895 · Received April 28, 2006

    Report

    Report Number
    1220394-2006-00001
    Event Type
    Other
    Date Received
    April 28, 2006
    Date of Event
    April 11, 2006
    Report Date
    April 28, 2006
    Manufacturer
    BBI DIAGNOSTICS
    Product Code
    MJX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TECHNOLOGIST REPORT EYE SPLASH WITH PRODUCT. SHE EXPERIENCED DIFFICULTY REMOVING THE PUSH AND PULL CAP FROM A VIAL OF THE PRODUCT (THE PRODUCT IS MANUFACTURED AND SHIPPED WITH A SCREW CAP, BUT THE LABORATORY REPLACED THE SCREW CAP WITH A PUSH AND PULL CAP). WHEN SHE APPLIED FORCETO THE CAP, A DROP OF PRODUCT ON THE CAP SPLASHED INTO HER LEFT EYE. TECHNOLOGIST WAS NOT WEARING PROTECTIVE EYEWEAR AND WAS WEARING CONTACT LENSES. SHE REMOVED HER CONTACT LENS AND FLUSHED HER EYE WITH WATER FOR APPROXIMATELY 10 MINUTES. TECHNOLOGIST WAS REFERRED TO THE HOSPITAL'S OUTPAIENT INFECTIOUS DISEASE SERVICE FOR FOLLOW-UP MEDICAL EVALUATION, AS THE PRODUCT CONTAINS CHEMICALLY TREATED HIV AND HEPATITIS POSITIVE RAW MATERIALS. AS A PRECAUTION, THE TECHNOLOGIST RECEIVED ANTI-HIV PROHYLAXIS AND A HEPATITIS B VACCINE, ALTHOUGH THE RISK OF INFECTION WAS FELT TO BE LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUN 1 MULTI-MARKER POSITIVE CONTROL 82MYZ MJX BBI DIAGNOSTICS SERIES 4400 109744

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other