BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 3790611 · Received May 5, 2014

    Report

    Report Number
    1628664-2014-00092
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    AFTER DISCUSSION WITH THE LOCAL ABBOTT FIELD SERVICE REPRESENTATIVE (FSR), IT WAS DETERMINED THE CUSTOMER HAD CONNECTED THE SUPPLY TUBING QUICK DISCONNECT FITTING TO THE DECONTAMINATION PORT 2 INSTEAD OF THE CONCENTRATED WASH BUFFER INLET CONNECTOR CAUSING PRESSURIZED DI WATER TO BACK FLOW INTO THE CONCENTRATED WASH BUFFER CONTAINER. NO PRODUCT DEFICIENCY AND NO MALFUNCTION WAS DETERMINED FOR THE ARCHITECT CONCENTRATED WASH BUFFER. REVIEW OF LABELING (PACKAGE INSERT AND MATERIAL SAFETY DATA SHEET) CONFIRMS THAT ALTHOUGH THE PRODUCT CONTAINS SODIUM AZIDE, IT IS NOT CLASSIFIED AS IRRITANT TO EYE AND SKIN. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE ARCHITECT ARM USER'S GUIDE PROVIDE THE OPERATOR ADEQUATE INFORMATION REGARDING OPERATION OF THE ARM; REPLACEMENT OF THE CONCENTRATION WASH BUFFER; DESCRIPTION OF THE ARM KEYPAD INDICATORS; PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR ERROR CODES 3901, 3902, AND OBSERVED PROBLEMS; AND SAFETY HAZARDS TO INCLUDE WEARING OF PERSONAL PROTECTIVE EQUIPMENT (PPE) AND SAFETY AWARENESS WHERE HAZARDS MAY EXIST. THE FSR RESOLVED THE ISSUE THROUGH NORMAL TROUBLESHOOTING PROCEDURES. NO ADDITIONAL TICKETS FOR (B)(4) RELATED TO THE ARM OR CONCENTRATED WASH BUFFER HAVE BEEN DOCUMENTED. NO TRENDS FOR TICKETS WITH REPLACEMENTS FOR THE ARCHITECT ARM WERE IDENTIFIED. BASED ON THE RESULTS OF THIS INVESTIGATION, THERE IS NO INDICATION OF A MALFUNCTION OR DEFICIENCY OF THE ARCHITECT ARM.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ON (B)(6) 2014, WHILE LOADING A NEW CONTAINER OF CONCENTRATED WASH BUFFER ONTO THE AUTOMATIC RECONSTITUTION MODULE (ARM) FOR USE ON THE ARCHITECT I2000SR ANALYZER, TWO LABORATORY EMPLOYEES WERE SPLASHED IN THE EYES WITH THE CONCENTRATED BUFFER WHEN ONE EMPLOYEE OPENED THE CAP ON THE CONTAINER. BOTH EMPLOYEES FLUSHED THEIR EYES FOR APPROXIMATELY 10 - 15 MINUTES AND WENT TO THE EMPLOYEE HEALTH DEPARTMENT. ONE EMPLOYEE HAD NO CORNEAL DAMAGE OR IRRITATION. THE OTHER EMPLOYEE HAD SLIGHT CORNEAL IRRITATION AND WAS GIVEN LUBRICATING EYE DROPS. FOLLOW-UP CONVERSATION WITH THE CUSTOMER ON (B)(6) 2014 INDICATED THAT THE EMPLOYEE WITH CORNEAL IRRITATION HAD NO FURTHER IRRITATION TO THE EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268953 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LIST 06C54-88, LOT 36223LF00| ARCHITECT CONCENTRATED WASH BUFFER