BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DCA VANTAGE ANALYZER

    MDR report key: 4838195 · Received June 11, 2015

    Report

    Report Number
    1217157-2015-00074
    Event Type
    Injury
    Date Received
    June 11, 2015
    Date of Event
    May 5, 2015
    Report Date
    June 1, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    LCP
    PMA / PMN Number
    K071466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DCA VANTAGE OPERATORS GUIDE STATES, "USING A SMOOTH, SLOW, CONTINUOUS MOTION, PULL THE FLEXIBLE PULL-TAB COMPLETELY OUT OF THE REAGENT CARTRIDGE." AND "WEAR PERSONAL PROTECTIVE EQUIPMENT, INCLUDING SAFETY GLASSES AND GLOVES. USE UNIVERSAL PRECAUTIONS." THE ISSUE OCCURRED WHILE PULLING THE FOIL BUFFER TAB BEFORE THE SAMPLE WAS PROCESSED. THIS WOULD INDICATE THAT THE BUFFER HAS NOT YET COME INTO CONTACT WITH AGGLUTINATOR, ANTIBODY LATEX, OXIDANT, OR PATIENT SAMPLE. AS PER SIEMENS MATERIAL SAFETY DATA SHEET (USA) FOR DCA SYSTEMS HEMOGLOBIN A1C REAGENT KIT ((B)(4)), HBA1C BUFFER SOLUTION HAS NO KNOWN SIGNIFICANT EFFECTS OR CRITICAL HAZARDS ON EYES. AS PER EU SAFETY DATA SHEET, CLASSIFICATION ACCORDING TO REGULATION (EC) NO. (B)(4) [CLP/GHS], HBA1C BUFFER SOLUTION IS NOT CLASSIFIED AS HAZARDOUS ACCORDING TO REGULATION (EC). SIEMENS FOLLOWED UP ON PATIENT'S HEALTH (EYE), CUSTOMER INDICATED THAT AT THIS MOMENT THE SYMPTOMS PERSISTING, OCULAR PRESSURE, FOREIGN BODY SENSATION, TEARING AND THEY ALSO MENTIONED FEEL BLURRED VISION AND EYE ZONE SWOLLEN THE EVENT HAS OCCURRED DUE TO AN OPERATOR ERROR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BUFFER SOLUTION SPLASHED INTO OPERATOR'S (NURSE) LEFT EYE WHEN SHE PULLED A PULL-TAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381221 DCA VANTAGE ANALYZER DCA LCP SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S