BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FC 500 FLOW CYTOMETER

    MDR report key: 15442246 · Received September 16, 2022

    Report

    Report Number
    1061932-2022-00059
    Event Type
    Malfunction
    Date Received
    September 16, 2022
    Date of Event
    August 22, 2022
    Report Date
    September 30, 2022
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    UDI-DI
    15099590572839
    PMA / PMN Number
    K071681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. SERIVCE IS SCHEDULED TO BE AT THE CUSTOMER SITE ON 20-SEPT- 2022. A FOLLOW UP WILL BE PROVIDED ONCE NEW INFORMATION BECOMES AVAILABLE. BEC INTERNAL IDENTIFIER - (B)(4).

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THE PLOTS ARE COMING OFF THE BASELINE AT THE FL2 POSITION ON THE FC500 WHEN RUNNING THEIR LDT (LABORATORY DESIGNED TEST) FOR LEUKEMIA/LYMPHOMA. THERE WAS AN INTERMITTENT UPWARD SIGNAL SHIFT AT THE FL2 POSITION CAUSING ERRONEOUS RESULTS FOR THEIR LEUKEMIA/LYMPHOMA LDT. THE CUSTOMER DISCARDED THE RESULTS AND RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT TO OBTAIN CORRECT RESULTS. THE CUSTOMER WAS ADVISED BY THE FIELD APPLICATIONS SPECIALIST TO CALL CUSTOMER TECHNICAL SUPPORT AND REQUEST REPLACEMENT OF THE TARPON AMP BOARD. WITH THE INFORMATION AVAILABLE AT THE INITIAL ASSESSMENT TWO TECHNICAL SUPPORT SUBJECT MATTER EXPERTS REVIEWED THE AVAILABLE DATA AND INFORMATION PROVIDED BY THE CUSTOMER AND BOTH INDICATED THAT THE EVENT DOES NOT APPEAR RELATED TO A TARPON BOARD MALFUNCTION. THE FIELD SERVICE ENGINEER (FSE) WAS AT THE CUSTOMER SITE ON 20-SEP-2022 AND REPLACED THE TARPON AMP BOARD AT THE AFFECTED LOCATION (FL2). BEC INTERNAL IDENTIFIER - (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER THAT THE PLOTS ARE COMING OFF THE BASELINE AT THE FL2 POSITION OF THEIR FC 500 FLOW CYTOMETER. THERE WAS AN INTERMITTENT UPWARD SIGNAL SHIFT AT THE FL2 POSITION CAUSING ERRONEOUS RESULTS FOR THEIR LEUKEMIA/LYMPHOMA LDT. THE CUSTOMER DISCARDED THE RESULTS AND RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT TO OBTAIN CORRECT RESULTS. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER THAT THE PLOTS ARE COMING OFF THE BASELINE AT THE FL2 POSITION OF THEIR FC 500 FLOW CYTOMETER. THERE WAS AN INTERMITTENT UPWARD SIGNAL SHIFT AT THE FL2 POSITION CAUSING ERRONEOUS RESULTS FOR THEIR LEUKEMIA/LYMPHOMA LDT. THE CUSTOMER DISCARDED THE RESULTS AND RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT TO OBTAIN CORRECT RESULTS. 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
    1603020 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