BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY SYSTEM

    MDR report key: 14568543 · Received June 1, 2022

    Report

    Report Number
    2919069-2022-00010
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    May 23, 2022
    Report Date
    August 18, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740099916
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    DURING THE SITE VISIT BY THE FIELD SERVICE ENGINEER (FSE) THE ANALYZER WAS INSPECTED AND DISCOVERED FOUND THAT THE HGB OUTPUT VOLTAGE WAS OUTSIDE OF SPECIFICATIONS. FIELD SERVICE REPLACED THE ASSY, HGB FLOW CELL, CDRUBY, ROHS, LIST NUMBER 8921292204, LOT NUMBER UNKNOWN. THE REPLACEMENT OF THE ASSY, HGB FLOW CELL WHICH RESOLVED THE ISSUE. A REVIEW OF THE CELL-DYN RUBY SYSTEM OPERATOR¿S MANUAL (9212934G¿NOVEMBER 2017) FOUND IN SECTION 10, "TROUBLESHOOTING AND DIAGNOSTICS". THE FOLLOWING STATEMENTS: "GENERALLY, CONDITIONS THAT ARE INSTRUMENT- OR REAGENT-RELATED WILL OCCUR ON ALL SAMPLES, INCLUDING CONTROLS. THEREFORE, IF A PROBLEM IS DETECTED OR SUSPECTED, IT IS IMPORTANT TO CONFIRM INSTRUMENT PERFORMANCE BY RERUNNING CONTROLS.... IF ASSISTANCE IS NEEDED FOR ANY TECHNICAL OR OPERATIONAL PROBLEMS, CALL YOUR LOCAL COUNTRY SERVICE AND SUPPORT CENTER." THIS SECTION ALSO PROVIDES STEPS FOR "TROUBLESHOOTING IMPRECISE OR INACCURATE DATA" INCLUDING HOW TO GATHER DATA AND REVIEW THE X-B TAB FROM THE MOVING AVERAGE PROGRAM TO VERIFY THAT THE HEMOGLOBIN REFERENCE VALUES ARE WITHIN 2050 +/- 250. THESE STEPS INSTRUCT THE OPERATOR TO CHECK THE HEMOGLOBIN FLOW CELL IF THE REFERENCE VALUE IS BELOW 1800 AND TO CALL THEIR LOCAL COUNTRY SERVICE AND SUPPORT CENTER IF THE REFERENCE VALUE IS GREATER THAN 2300. LABELING WAS FOUND TO BE ADEQUATE FOR THE COMPLAINT ISSUE. BASED ON THIS INVESTIGATION A PRODUCT DEFICIENCY WAS NOT IDENTIFIED FOR CELL-DYN RUBY ANALYZER, LIST NUMBER 08H67-01, SERIAL NUMBER (B)(6) OR ASSY, HGB FLOW CELL, CDRUBY, ROHS.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED DISCREPANT HEMOGLOBIN RESULTS ON CELL-DYN RUBY ANALYZER FOR ONE PATIENT. THE RESULTS PROVIDED WERE: INITIAL=7.4 G/DL /REPEATED=7.8 G/DL /REPEATED ON ANOTHER RUBY (B)(4)=9.4 G/DL /REPEATED=9.8 G/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323572 CELL-DYN RUBY SYSTEM COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 08H67-03 00380740099916

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown