BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY SYSTEM

    MDR report key: 11401949 · Received March 2, 2021

    Report

    Report Number
    2919069-2021-00006
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Date of Event
    February 12, 2021
    Report Date
    June 15, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740017170
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COMPONENT CODE: G03001. ON FEBRUARY 12, 2021 WHILE THE CUSTOMER TECHNICAL ADVOCATE WALKED A CUSTOMER THROUGH THE VP-34 OPTICAL FLOW CELL CLEANING ON THE CELL-DYN RUBY, 08H67-01, SERIAL NUMBER: (B)(6) , THE TUBING POPPED OFF THE 10ML SYRINGE BEING USED FOR CLEANING PROCEDURE AND SPLASHED THE CUSTOMER WITH 1% SODIUM HYPOCHLORITE SOLUTION IN THE FACE AND ONTO THEIR SHIRT. THE OPERATOR WAS NOT WEARING SAFETY GLASSES AT THE TIME. THE CUSTOMER WIPED AND CLEANED THE BLEACH SOLUTION FROM THEIR CHEEK. THE CUSTOMER CONFIRMED THAT NO INJURY OCCURRED, AND NO MEDICAL ATTENTION WAS REQUIRED. THE INVESTIGATION INCLUDED REVIEW OF PRODUCT HISTORICAL DATA, PRODUCT LABELING, AND CONSULTATION WITH SUBJECT MATTER EXPERT. REVIEW OF PRODUCT HISTORICAL DATA FOR ANY TRENDS AND ALL CUSTOMER COMPLAINTS RECEIVED FOR THIS ISSUE DID NOT IDENTIFY ANY TRENDS OR ABNORMAL COMPLAINT ACTIVITY. REVIEW OF HISTORICAL DATA DID NOT FIND A PRODUCT ISSUE RELATED TO THE COMPLAINT INCIDENT. LABELING WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. REVIEW OF THE CELL-DYN RUBY OPERATOR'S MANUAL, LIST 9140559, REV. G, NOVEMBER 2017, FOUND PAGE 5-16 SPECIMEN ANALYSIS, PREPARING AND HANDLING SPECIMENS SECTION PROVIDES STATEMENT, "WEAR LAB COATS, PROTECTIVE EYE WEAR, AND GLOVES, AND FOLLOW BIOSAFETY PRACTICES AS SPECIFIED IN THE OSHA BLOODBORNE PATHOGEN RULE (29 CFR PART 1910.1030) OR OTHER EQUIVALENT BIOSAFETY PROCEDURES." A REVIEW OF THE CELL-DYN RUBY RISK ANALYSIS CD34-SYS-104, VERSION 10.4 DETERMINED THAT THIS HAZARDOUS SITUATION HAS CONTROL MEASURES IN PLACE, SUCH AS INSTRUCTIONS IN THE OPERATOR¿S MANUAL TO WEAR APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT AND FOLLOW BIOSAFETY PRACTICES. IN ADDITION, THE OTHER CONTROL METHOD IS TO HAVE A RELEASED SERVICE PROCEDURE TO DESCRIBE PARTS, ASSEMBLIES AND INSTRUCTIONS TO BE FOLLOWED. IN THIS CASE, THE SERVICE PROCEDURE IS VP-34. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE CELL-DYN RUBY ANALYZER.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP IS SUBMITTED, TO POPULATE FIELDS D8 AND/OR H6 WITH DATA, THAT HAD PREVIOUSLY BEEN PROVIDED IN FIELD H10. THERE IS NO CHANGE TO THE CONTENT OF THE DATA.

    Additional Manufacturer Narrative · 1

    (B)(4). WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED AN INCREASE IN EXCESSIVE FLAGGING OF CBC DIFFERENTIALS WHILE RUNNING ON THE CELL-DYN RUBY ANALYZER FOR NORMAL SAMPLES. THE CUSTOMER CONFIRMED DIFFERENTIAL RESULTS FROM THE MANUAL BLOOD SMEARS, THEREFORE NO DISCREPANT RESULTS WERE REPORTED. DURING TROUBLESHOOTING, THE CUSTOMER TECHNICAL SUPPORT INSTRUCTED THE CUSTOMER TO PERFORM AN OPTICAL FLOW CELL CLEANING. DURING THE PROCEDURE, THE TUBING FROM THE 10 ML SYRINGE CONTAINING 1% SODIUM HYPOCHLORITE SOLUTION BEING USED FOR THE CLEANING PROCEDURE SPLASHED THE CUSTOMER ON THE CHEEK. THE BLEACH SOLUTION DID NOT ENTER THE EYES, NOSE, OR MOUTH OF THE CUSTOMER. AT THE TIME OF THE INCIDENT, THE CUSTOMER WAS NOT WEARING SAFETY GLASSES OR FACE SHIELD. THERE WAS NO INJURY/INTERVENTION TO THE CUSTOMER REPORTED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294693 CELL-DYN RUBY SYSTEM COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 08H67-01 00380740017170

    Patients

    Seq Age Sex Outcome Treatment
    1