BEUDAMED
    FDA Adverse Event Other Summary report: N

    DCA SYSTEMS

    MDR report key: 1728305 · Received June 14, 2010

    Report

    Report Number
    1217157-2010-00011
    Event Type
    Other
    Date Received
    June 14, 2010
    Date of Event
    May 27, 2010
    Report Date
    May 27, 2010
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    JIR
    PMA / PMN Number
    K963142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN WAS ADVISED OF PROPER TECHNIQUE FOR REMOVING CARTRIDGES. OPERATOR REFERENCE GUIDE ADVISES: "TO REMOVE CARTRIDGE - HOLD BUTTON DOWN WITH RIGHT HAND. WITH LEFT HAND, GENTLY PULL TAB ON CARTRIDGE TO RIGHT TO UNLOCK. PULL UPWARD, DISCARDED CARTRIDGE TO PREVENT INJURY AND POSSIBLE CONTAMINATION TO OTHERS".

    Description of Event or Problem · 1

    A MEDICAL TECHNICIAN WAS SPLASHED IN THE EYE WITH HEMOGLOBIN A1C REAGENT AND PT SAMPLE WHEN SHE ATTEMPTED TO REMOVE A CARTRIDGE USING A PAIR OF SCISSORS. THE SAMPLE WAS REPORTED TO BE FROM A PT WITH (B)(6). THE TECHNICIAN WAS SENT TO THE EMERGENCY ROOM FOR FOLLOW UP TREATMENT. THE TECHNICIAN WAS NOT WEARING SAFETY GLASSES AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DCA SYSTEMS DCA SYSTEMS JIR BAYER HEALTHCARE LLC 2000/2000+

    Patients

    Seq Age Sex Outcome Treatment
    1