BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY

    MDR report key: 23067259 · Received September 16, 2025

    Report

    Report Number
    2919069-2025-00041
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    September 2, 2025
    Report Date
    September 16, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740017170
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1 PATIENT IDENTIFIER: COMPLETE LIST OF SAMPLE ID'S ARE (B)(6). THE CELL DYN RUBY ANALYZER SERIAL NUMBER (B)(6) WAS EVALUATED AND IT WAS DETERMINED THAT MULTIPLE PARTS REQUIRED CLEANING. THE ANALYZER FUNCTION WAS VERIFIED WITH A PRECISION RUN. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL COMPLAINTS ASSOCIATED WITH THE CUSTOMER REPORTED EVENT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE CELL DYN RUBY ANALYZER WITH REGARDS TO THE CUSTOMER REPORTED EVENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES FOR THE CELL DYN RUBY ANALYZER AS IT RELATES TO THE CUSTOMER REPORTED EVENT. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE CELL DYN RUBY ANALYZER SERIAL NUMBER (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED PLATELET RESULTS GENERATED ON THE CELL DYN RUBY ANALYZER AFTER IT ENTERS A PROLONGED IDLE STATE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE VALUES PLT 150-450 10E3/UL; RBC 4.2-5.4 10E6/UL; WBC 5-10 10E3/UL): PATIENT 1 SID (B)(6) 03/09/2025 7:04. WBC 6.24 10E3/UL. RBC 1.88 10E6/UL. PLT 989 10E3/UL. SID NO ID (IT IS THE SAME SAMPLE) 03/09/205 7:30. WBC 5.88 10E3/UL. RBC 2.33 10E6/UL. PLT 570 10E3/UL. SID (B)(6) 03/09/2025 7:44. WBC 9.65 10E3/UL. RBC 3.40 10E6/UL. PLT 323 10E3/UL. PATIENT 2 SID (B)(6) 03/09/2025 3:37. WBC 5.25 10E3/UL. RBC 2.12 10E6/UL. PLT 984 10E3/UL. SID NO ID (IT IS THE SAME SAMPLE) 03/09/205 3:40. WBC 5.17 10E3/UL. RBC 3.08 10E6/UL. PLT 277 10E3/UL. SID (B)(6) 03/09/2025 3:42. WBC 5.56 10E3/UL RBC 3.20 10E6/UL. PLT 285 10E3/UL. PATIENT 3 SID (B)(6) 02/09/2025 6:50. PLT 1055 10E3/UL RBC 1.56 10E6/UL WBC 5.88 10E3/UL SID (B)(6) 02/09/2025 7:01. PLT 341 10E3/UL RBC 2.57 10E6/UL WBC 6.27 10E3/UL SID (B)(6) 02/09/2025 7:08. PLT 336 10E3/UL RBC 2.57 10E6/UL WBC 6.15 10E3/UL SID (B)(6) 02/09/2025 7:11. PLT 1016 10E3/UL RBC 1.67 10E6/UL WBC 6.42 10E3/UL SID (B)(6) 02/09/2025 7:14. PLT 663 10E3/UL RBC 2.06 10E6/UL WBC 6.03 10E3/UL SID (B)(6) 02/09/2025 7:28. PLT 385 10E3/UL RBC 3.33 10E6/UL WBC 9.53 10E3/UL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2650704 CELL-DYN RUBY COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740017170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown