BEUDAMED
    FDA Adverse Event Other Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS AMBS QUANTITATIVE REAGENT PACK

    MDR report key: 865780 · Received June 14, 2007

    Report

    Report Number
    9680658-2007-00168
    Event Type
    Other
    Date Received
    June 14, 2007
    Date of Event
    May 18, 2007
    Report Date
    May 18, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING STATEMENT APPEARS IN THE WARNINGS AND PRECAUTIONS OF THE IFU REGARDING THE INFECTIONS STATUS OF REAGENT FLUIDS: "CARE SHOULD BE TAKEN WHEN HANDLING MATERIAL OF HUMAN ORIGIN. ALL SAMPLES SHOULD BE CONSIDERED POTENTIALLY INFECTIONS. NO TEST METHOD CAN OFFER COMPLETE ASSURANCE THAT HEPATITIS B VIRUS, HIV 1+2 OR OTHER INFECTIOUS AGENTS ARE ABSENT. HANDLING OF SAMPLES AND ASSAY COMPONENTS, THEIR USE, STORAGE AND SOLID AND LIQUID WASTE DISPOSAL SHOULD BE DONE AT BIOLOGICAL SAFETY LEVEL 2 AND IN ACCORDANCE WITH THE PROCEDURES DEFINED BY THE APPROPRIATE NATIONAL BIOHAZARD SAFETY GUIDELINE OR REGULATION (E.G. NCCLS GUIDELINE M29)." NO TREATMENT HAS BEEN INITIATED. THE CAUSE OF THE EXPOSURE WAS USER ERROR IN NOT PROPERLY POSITIONING PERSONAL PROTECTIVE EQUIPMENT WHILE HANDLING THE SAMPLE WELLS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED SPLASHING REAGENT INTO THEIR EYES WHILE MANUALLY REMOVING WELLS FROM THE OUTER INCUBATOR RING OF THE VITROS ECIQ ANALYZER. SEVERAL INFECTIOUS DISEASE ASSAYS WERE BEING TESTED AT THIS TIME AND THE WELLS CONTAINED BOTH HUMAN SAMPLES AND BLOOD PRODS. THE SUBJECT IMMEDIATELY WASHED HER EYES WITH AN EYE WASH STATION AND WENT TO THE HOSP'S ER FOR ADD'L EYE WASH TREATMENT. THERE WAS NOT IMMEDIATE HARM TO THE SUBJECT AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS AMBS QUANTITATIVE REAGENT PACK IN VITRO DIAGNOSTIC LOM ORTHO-CLINICAL DIAGNOSTICS NA 5380

    Patients

    Seq Age Sex Outcome Treatment
    1 YR