BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXSYM REA ETHANOL REAGENT

    MDR report key: 619727 · Received July 7, 2005

    Report

    Report Number
    2623532-2005-00002
    Event Type
    Other
    Date Received
    July 7, 2005
    Date of Event
    June 8, 2005
    Report Date
    July 7, 2005
    Manufacturer
    ABBOTT HEALTH PRODUCTS, INC.
    Product Code
    DML
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES TH AT THEIR LAB USED SYRINGES TO ASPIRATE ABBOTT ETHANOL CONTROLS FROM THEIR VIALS AND DISPENSE THE SOLUTION INTO SAMPLE CUPS FOR ANALYSIS. WHILE DISPENSING CONTROL INTO A SAMPLE CUP, THE CUSTOMER STUCK THEIR THRUMB WITH THE SYRINGE. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE FAXED A MSDS TO THE CUSTOMER. THE CUSTOMER IS BEING TESTED FOR HIV, HCV AND HEPATITIS B AND RECEIVED A TETANUS SHOT. THERE IS NO IMPACT TO PT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM REA ETHANOL REAGENT QUANTITATIVE REA FOR THE MEASUREMENT OF ALCOH DML ABBOTT HEALTH PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other