BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE SYSTEM

    MDR report key: 16931318 · Received May 15, 2023

    Report

    Report Number
    2919069-2023-00014
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Date of Event
    May 2, 2023
    Report Date
    May 31, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740016616
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED FALSELY DECREASED WBC AND NEUTROPHIL RESULTS FOR TWO PATIENTS ON THE CELL-DYN SAPPHIRE, SERIAL NUMBER (S/N) (B)(6). THE ISSUE WAS RESOLVED AFTER FIELD SERVICE RESEATED TUBING (PART NUMBER 9130687) AND FLUSHED THE AFFECTED (WBC) PATHWAYS. A REVIEW OF ALL COMPLAINTS ASSOCIATED AND A REVIEW OF COMPLAINT TRENDS FOR THE LIST NUMBER WAS PERFORMED. THE REVIEW DID NOT IDENTIFY ANY ADVERSE TRENDS. ADDITIONALLY, LABELING WAS REVIEWED AND ADEQUATELY ADDRESSED THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE CELL-DYN SAPPHIRE, SERIAL NUMBER (S/N) (B)(6) WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETE INFORMATION FOR SECTION A1 PATIENT IDENTIFIER: SID (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED WBC AND NEUTROPHIL RESULTS GENERATED ON THE CELL-DYN SAPPHIRE ANALYZER FOR 2 SAMPLES THAT WERE NOT REPORTED OUT. THE SAMPLES WERE REPEATED WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: BOTH SAMPLES PROCESSED ON (B)(6) 2023. SID (B)(6) INITIAL WBC RESULT = 0.436 10E3/UL REPEAT WBC = 11.7 10E3/UL INITIAL NEUTROPHIL RESULT = 0.024 10E3/UL REPEAT RESULT = 7.86 10E3/UL. SID (B)(6) INITIAL WBC RESULT = 0.365 10E3/UL REPEAT WBC = 7.77 10E3/UL INITIAL NEUTROPHIL RESULT = 0.049 10E3/UL REPEAT RESULT = 5.64 10E3/UL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475493 CELL-DYN SAPPHIRE SYSTEM COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 08H00-01 00380740016616

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown