BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 4182472 · Received October 17, 2014

    Report

    Report Number
    2919069-2014-00066
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (NO PATIENT INVOLVEMENT). (OBSTRUCTION WITHIN DEVICE).

    Additional Manufacturer Narrative · 1

    A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. SECTION 8 OF THE CELL-DYN RUBY SYSTEM OPERATOR'S MANUAL PROVIDES INFORMATION ON POTENTIAL HAZARDS TO PERSONNEL AND POTENTIAL DAMAGE TO THE LABORATORY ENVIRONMENT. SECTION 8, PAGE 2, TABLE 8.1 SAFETY ICONS AND DESCRIPTIONS, PROVIDES THE ICON SYMBOL, HAZARD, AND DESCRIPTION. SECTION 8, PAGE 7, ADVISES OPERATORS TO WEAR APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT AND FOLLOW BIOSAFETY PRACTICES. THE FIELD SERVICE PERSONNEL WAS WEARING GLASSES AND GLOVES, BUT NOT A LABORATORY GOWN. HISTORICAL COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THIS INCIDENT WAS AN ISOLATED INCIDENT WHICH INVOLVED ONE SPECIFIC CD RUBY INSTRUMENT, SERIAL NUMBER (B)(4). BASED ON THE INVESTIGATION, WHICH INCLUDED REVIEW OF PRODUCT HISTORICAL DATA AND LABELING, A PRODUCT DEFICIENCY WAS NOT IDENTIFIED FOR THE CELL-DYN RUBY SYSTEM, LIST NUMBER 08H67-01.

    Description of Event or Problem · 1

    AN ABBOTT FIELD SERVICE ENGINEER (FSE) ATTENDED THE CUSTOMER SITE TO TROUBLESHOOT A CLOGGED WASTE LINE ON THE CELL-DYN RUBY ANALYZER. WHILE ATTEMPTING TO FLUSH THE WASTE LINE WITH BLEACH, LIQUID WASTE WAS SPLASHED INTO HIS EYES AND MOUTH. THE CELL-DYN RUBY ANALYZER WAS POWERED OFF WHEN THE SPLASH OCCURRED. THE FSE WAS WEARING SAFETY GLASSES AND GLOVES. HE IMMEDIATELY WASHED HIS FACE AND WENT TO SEE THE INFECTION SPECIALIST AT THE CUSTOMER SITE. BLOOD TESTING WAS PERFORMED. THE PHYSICIAN RECOMMENDED THAT THE FSE RECEIVE A VACCINE FOR HEPATITIS. NO VACCINE OR OTHER MEDICAL TREATMENT WAS GIVEN AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660896 CELL-DYN RUBY ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1