BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 4102859 · Received September 19, 2014

    Report

    Report Number
    1628664-2014-00209
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 25, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    NO RETURNS WERE AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. INFORMATION FROM THE CUSTOMER INDICATES THAT A VACUUM CLEANER WAS USED TO REMOVE LIQUID WASTE FROM AROUND THE AREA OF THE EXTERNAL WASTE PUMP AND FLOOR DRAIN. THE EXTERNAL WASTE PUMP CONNECTED TO THE ARCHITECT I2000SR ANALYZER ((B)(4)) WAS POWERED OFF AT THE TIME AND BOTH THE INLET TUBING AND OUTLET TUBING WERE CONNECTED TO THE PUMP. THE CUSTOMER NOTES THAT THE ARCHITECT I2000SR ANALYZER WAS NOT RUNNING AT THE TIME AND NEITHER THE ANALYZER NOR THE EXTERNAL WASTE PUMP CAUSED THE SPLASHING INCIDENT. THE CUSTOMER WAS UNABLE TO DETERMINE THE EXACT ORIGIN OF THE LIQUID. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE EXTERNAL WASTE PUMP INSTRUCTION MANUAL BOTH PROVIDE INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER SITE AND FROM THE RESULTS OF THIS EVALUATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST A PRODUCT MALFUNCTION OCCURRED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A SPLASH IN THE EYES WITH LIQUID WASTE GENERATED BY THE ARCHITECT I2000SR ANALYZER. THE WASTE HAD BEGUN ACCUMULATING ON THE FLOOR OF THE LAB BECAUSE THE ANALYZER'S EXTERNAL WASTE PUMP WAS OFF. DURING THE CLEAN UP OF THE LIQUID, THE OPERATOR WAS SPLASHED IN THE EYES. SHE FLUSHED HER EYES WITH WATER BUT HER EYES CONTINUED TO EXPERIENCE A BURNING SENSATION AND SHE WENT TO THE EMERGENCY DEPARTMENT WHERE EYE DROPS WERE ADMINISTERED. THE OPERATOR WAS NOT WEARING ANY EYE PROTECTION AT THE TIME OF THE INCIDENT. THE OPERATOR HAS RETURNED TO WORK WITH NO OTHER SYMPTOMS HAVING DEVELOPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584778 ARCHITECT I2000SR ANALYZER ARCHITECT I2000SR ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTERNAL WASTE PUMP LN: 08C94-99