BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY

    MDR report key: 21729864 · Received March 31, 2025

    Report

    Report Number
    2919069-2025-00013
    Event Type
    Malfunction
    Date Received
    March 31, 2025
    Date of Event
    March 12, 2025
    Report Date
    April 21, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740017170
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    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

    THE CELL-DYN RUBY ANALYZER, SERIAL NUMBER (B)(6), WAS CONSIDERED THE LIKELY CAUSE OF THE RESULT ISSUE AS A SINGLE DEFINITIVE PART COULD NOT BE DETERMINED AND NO TROUBLESHOOTING WAS PERFORMED. THE SAMPLE WAS TESTED IN BOTH THE CBC + RRBC AND CBC + NOC TEST MODES WITH CONSISTENTLY ELEVATED WBC RESULTS ON THE RUBY; HOWEVER, THERE WAS SUSPECT FLAGGING ON THE WBC RESULTS AND OTHER PARAMETERS. A SMEAR REVIEW SHOWED THE PRESENCE OF NRBCS. AN INSTRUMENT SERVICE HISTORY FOR THE 70226BG FOUND NO ADDITIONAL COMPLAINTS OF DISCREPANT WBC, OR HGB REPORTED AFTER THE CURRENT EVENT WAS IDENTIFIED. A REVIEW OF THE CELL-DYN RUBY ANALYZER (LIST NUMBER 08H67-01), DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE CURRENT ISSUE. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES WERE IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE CELL-DYN RUBY ANALYZER, SERIAL NUMBER (B)(6), WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED WBC RESULTS AND DISCREPANT HEMOGLOBIN RESULTS GENERATED BY THE CELL-DYN RUBY ANALYZER FOR A PATIENT, WHICH WERE INCONSISTENT WITH THE RESULTS FROM THE SYSMEX. THE BLOOD SMEAR WAS REVIEWED AND SHOWED THE PRESENCE OF NUCLEATED RBCS (NRBCS). THE FOLLOWING DATA WERE PROVIDED: ON (B)(6) 2025 SAMPLE ID: (B)(6) SEQUENCE#: 4570 (CBC+ RRBC TEST MODE). RUBY WBC RESULT = 92.7 X 10E3/ L (INVALIDATED WITH AN ASTERISK). RUBY HGB RESULT = 8.15 G/DL. FLAGS PRESENT: (NOC)WBC, FWBC/NWBC, DFLT (NLMEB), VAR LYM, RBC MORPH. THE CUSTOMER RELEASED THE RESULTS FROM SEQUENCE #4570 OUT OF THE LAB. UPON REVIEWING THE BLOOD SMEAR, NUMEROUS NRBCS WERE SEEN. THE SAMPLE WAS REPEATED ON THE CELL-DYN RUBY IN CBC + NOC TEST MODE AS WELL AS ON THE SYSMEX PLATFORM. THE FOLLOWING DATA WERE PROVIDED: ON (B)(6) 2025 SAMPLE ID: (B)(6) SEQUENCE#: 4571 (CBC+ NOC TEST MODE). RUBY WBC RESULT = 89.5 X 10E3/ L. RUBY HGB RESULT = 7.25 G/DL. FLAGS PRESENT: NOC, FWBC, DFLT (NLMEB), RBC MORPH. ON (B)(6) 2025 SYSMEX RESULTS: WBC = 16.31 X 10E3/ L. HGB = 5.8 G/DL. FLAGS PRESENT: WBC ABN SCATTERGRAM, LYMPHOCYTOSIS, MONOCYTOSIS, NRBC PRESENT, IG PRESENT, BLASTS/ABN LYMPHO, ANISOCYTOSIS, MACROCYTOSIS, ANEMIA, PLT CLUMPS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED WBC RESULTS AND DISCREPANT HEMOGLOBIN RESULTS GENERATED BY THE CELL-DYN RUBY ANALYZER FOR A PATIENT, WHICH WERE INCONSISTENT WITH THE RESULTS FROM THE SYSMEX. THE BLOOD SMEAR WAS REVIEWED AND SHOWED THE PRESENCE OF NUCLEATED RBCS (NRBCS). THE FOLLOWING DATA WERE PROVIDED: (B)(6) 2025 SAMPLE ID: (B)(6) SEQUENCE# 4570 (CBC+ RRBC TEST MODE). RUBY WBC RESULT = 92.7 X 10E3/¿L (INVALIDATED WITH AN ASTERISK). RUBY HGB RESULT = 8.15 G/DL. FLAGS PRESENT: (NOC)WBC, FWBC/NWBC, DFLT (NLMEB), VAR LYM, RBC MORPH THE CUSTOMER RELEASED THE RESULTS FROM SEQUENCE #4570 OUT OF THE LAB. UPON REVIEWING THE BLOOD SMEAR, NUMEROUS NRBCS WERE SEEN. THE SAMPLE WAS REPEATED ON THE CELL-DYN RUBY IN CBC + NOC TEST MODE AS WELL AS ON THE SYSMEX PLATFORM. THE FOLLOWING DATA WERE PROVIDED: (B)(6) 2025 SAMPLE ID: (B)(6). SEQUENCE# 4571 (CBC+ NOC TEST MODE). RUBY WBC RESULT = 89.5 X 10E3/¿L. RUBY HGB RESULT = 7.25 G/DL. FLAGS PRESENT: NOC, FWBC, DFLT (NLMEB), RBC MORPH. (B)(6) 2025 SYSMEX RESULTS: WBC = 16.31 X 10E3/¿L HGB = 5.8 G/DL FLAGS PRESENT: WBC ABN SCATTERGRAM, LYMPHOCYTOSIS, MONOCYTOSIS, NRBC PRESENT, IG PRESENT, BLASTS/ABN LYMPHO, ANISOCYTOSIS, MACROCYTOSIS, ANEMIA, PLT CLUMPS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041764 CELL-DYN RUBY COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740017170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown