BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FC 500 FLOW CYTOMETER

    MDR report key: 15175461 · Received August 5, 2022

    Report

    Report Number
    1061932-2022-00050
    Event Type
    Malfunction
    Date Received
    August 5, 2022
    Date of Event
    July 11, 2022
    Report Date
    August 5, 2022
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    UDI-DI
    15099590572839
    PMA / PMN Number
    K071681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE AND OBSERVED THAT THE CAROUSEL WAS DAMAGED, ALTERED AND MISSING CAROUSEL POSITION LABELS. THE LABEL AT POSITION 5 HAD TAPE OVER IT. THE LABELS AT POSITIONS 7, 10 AND 32 WERE MISSING. IT WAS ALSO OBSERVED THAT THE CUSTOMER CREATED THEIR WORKLIST MANUALLY. PER THE CUSTOMER, BARCODE LABELS WERE AFFIXED TO THE SAMPLE TUBES. THE CUSTOMER ENTERS THE CAROUSEL NUMBER MANUALLY AND THE TUBE POSITIONS ARE SCANNED BY THE SYSTEM. THE WORKLIST/PATIENT DATA COULD NOT BE PROVIDED AS IT HAD ALREADY BEEN CLEARED BY THE CUSTOMER. BASED ON THE AVAILABLE INFORMATION THE FAILURE CAUSE CANNOT BE DEFINITIVELY IDENTIFIED. THE FAILURE WAS MOST LIKELY DUE TO THE DAMAGED, ALTERED, AND MISSING CAROUSEL POSITION LABELS OR AN ERROR IN CREATING THE WORKLIST MANUALLY. BEC INTERNAL IDENTIFIER - (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEIR FC 500 FLOW CYTOMETER DREW SAMPLE OUT OF THE POSITIVE CONTROL TUBE INSTEAD OF THE PATIENT SAMPLE TUBE FOR CAROUSEL POSITIONS 4 AND 10. THIS RESULTED IN ERRONEOUSLY HIGH(POSITIVE) FETAL HEMOGLOBIN (HG-F) RESULTS FOR THE PAITENTS AT THE INDICATED POSITIONS. RESULTS WERE NOT REPORTED OUTSIDE OF THE LAB. THE SAMPLES WERE RE-ANALYZED AND CORRECT RESULTS WERE OBTAINED. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2433881 FC 500 FLOW CYTOMETER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER TN FC500 FLOW CYTOMETER 100-240V 50/60HZ 15099590572839

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown