BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 560 AL COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 23033802 · Received September 11, 2025

    Report

    Report Number
    1061932-2025-00027
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    August 1, 2025
    Report Date
    September 11, 2025
    Manufacturer
    BECKMAN COULTER IRELAND INC
    Product Code
    GKZ
    PMA / PMN Number
    K181475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THE MAIN BOARD WAS FAULTY CAUSING THE ISSUE. THE FSE REPLACED THE MAIN BOARD, SHEAR VALVE AND RBC BATH O-RING RESOLVING THE EVENT. THE INSTRUMENT WAS VERIFIED TO BE OPERATIONAL PER ESTABLISHED TEST AND INSPECTION PROCEDURES. BEC INTERNAL IDENTIFIER- (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT PATIENT SAMPLES ARE RECOVERING WITH ERRONEOUS HIGH PLATELET (PLT) RESULTS WITH SUSPECT MESSAGING WHEN CYCLED ON THE DXH560 AL HEMATOLOGY INSTRUMENT COMPARED TO A RERUN OF THE SAMPLE ON AN ALTERNATE INSTRUMENT. ERRONEOUS RESUTLS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT OF DEATH, INJURY, DELAY OR CHANGE TO PATIENT TREATMENT OR DIAGNOSIS. THERE WAS NO REPORT OF HARM TO PATIENT OR USER. PRINTOUTS OF THE EVENT WERE PROVIDED. PRINTOUTS RECEIVED INDICATED TWO PATIENT SAMPLES (SAMPLE 1 AND SAMPLE 2) RECOVERED WITH LOW WBC, RBC, RED CELL DISTRIBUTION WIDTH (RDW) AND MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION (MCHC) WITH HIGH HEMATOCRIT (HCT), MEAN CORPUSCULAR HEMOGLOBIN (MCH), MEAN PLATELET VOLUME (MPV) AND PLT RESULTS COMPARED TO AN ALTERNATE INSTRUMENT THE CUSTOMER BELIEVES TO BE CORRECT. BOTH RUNS RECOVERED WITH SUSPECT MESSAGING. ALL OTHER PARAMETERS CORRELATED BETWEEN RUNS. THE THIRD PRINTOUTS RECEIVED INDICATED ONE PATIENT SAMPLE (SAMPLE 3) RECOVERED WITH LOW WBC, RBC AND RDW AND HIGH HCT, MCH, PLT AND MEAN CORPUSCULAR VOLUME (MCV) RESULTS COMPARED TO AN ALTERNATE INSTRUMENT THE CUSTOMER BELIEVES TO BE CORRECT. BOTH RUNS RECOVERED WITH SUSPECT MESSAGING. ALL OTHER PARAMETERS CORRELATED BETWEEN RUNS. THE NEXT PRINTOUTS RECEIVED INDICATED ONE PATIENT SAMPLE (SAMPLE 4) RECOVERED WITH LOW WBC, RBC, HCT, RDW AND HIGH MCH, MCHC, PLT AND MPV RESULTS COMPARED TO AN ALTERNATE INSTRUMENT THE CUSTOMER BELIEVES TO BE CORRECT. BOTH RUNS RECOVERED WITH SUSPECT MESSAGING. ALL OTHER PARAMETERS CORRELATED BETWEEN RUNS. THE LAST PRINTOUTS RECEIVED INDICATED ONE PATIENT SAMPLE (SAMPLE 5) RECOVERED WITH LOW WBC, RBC, HCT AND HIGH MCH, MCHC, PLT AND MPV RESULTS WITH SUSPECT MESSAGING COMPARED TO AN ALTERNATE INSTRUMENT THE CUSTOMER BELIEVES TO BE CORRECT. ALL OTHER PARAMETERS CORRELATED BETWEEN RUNS. ONSITE SERVICE WAS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305548 UNICEL DXH 560 AL COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER IRELAND INC DXH 560 AL HEMATOLOGY ANALYZER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown