BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXH 500 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 19792950 · Received July 22, 2024

    Report

    Report Number
    1061932-2024-00008
    Event Type
    Injury
    Date Received
    July 22, 2024
    Date of Event
    April 16, 2024
    Report Date
    July 22, 2024
    Manufacturer
    BECKMAN COULTER IRELAND INC
    Product Code
    GKZ
    UDI-DI
    15099590671242
    PMA / PMN Number
    K181475
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE BEC FIELD SERVICE MANAGER, THE INSTRUMENT HAS BEEN MAINTAINED REGULARLY AS REQUIRED. THE INSTRUMENT IS FUNCTIONAL AND IN GOOD CONDITION. THE LABORATORY DEPARTMENT HEAD STATED THAT THE ISSUE WAS CAUSED BY IMPROPER PRE-PROCESSING OF THE SAMPLE. THIS RULED OUT THE INITIAL CLAIM OF AGING AND CLOGGING AS THE CAUSE OF THE EVENT. PER INSTRUCTIONS FOR USE DXH 500, PART C42118AA: CAUTION: RISK OF ERRONEOUS RESULTS. BECKMAN COULTER DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN ALL SAMPLES AND SUGGESTS USING ALL AVAILABLE FLAGGING OPTIONS TO OPTIMIZE THE SENSITIVITY OF INSTRUMENT RESULTS. THE OPTIONS INCLUDE DEFINITIVE MESSAGES, SYSTEM MESSAGES, PARAMETER FLAGS AND CODES, AND REFERENCE INTERVAL (H/L) AND ACTION LIMITS (H/L) FLAGS. BECKMAN COULTER RECOMMENDS AVOIDING THE USE OF SINGLE MESSAGES OR OUTPUTS TO SUMMARIZE SPECIMEN RESULTS OR PATIENT CONDITIONS. THERE MAY BE SITUATIONS WHERE THE PRESENCE OF A RARE EVENT MAY FAIL TO TRIGGER A SYSTEM MESSAGE. IMPORTANT: BECKMAN COULTER RECOMMENDS ANALYZING REFRIGERATED AND NON-REFRIGERATED WHOLE-BLOOD SAMPLES WITHIN EIGHT HOURS. PER TABLE 1.19 SAMPLE STABILITY AND STORAGE PARAMETER: PLT (X 103 CELLS/L) CONTROLLED ROOM TEMPERATURE 18 TO 26°C (64 TO 79°F): 24 HOURS REFRIGERATED TEMPERATURE 2 TO 8°C (35.6 TO 46.4°F): 24 HOURS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEIR DXH 500 HEMATOLOGY INSTRUMENT GENERATED AN ERRONEOUSLY HIGH PLATELET (PLT) RESULT FOR ONE PATIENT SAMPLE. THE PATIENT DISCONTINUED MEDICATION FOR THEIR THROMBOCYTOPENIA CAUSING DISEASE PROGRESSION. THE PATIENT ARRIVED TO THE CLINIC ON 16-APRIL-2024, FOR TREATMENT OF THROMBOCYTOPENIA. WHEN TESTED, THE PATIENT SAMPLE REFLECTED NORMAL PLATELET PARAMETER RESULT. HOWEVER, THREE DAYS AFTER THE PATIENT STOPPED TAKING MEDICATION, THEY BEGAN TO SUFFER FROM GUM BLEEDING. THE PATIENT WENT TO A DIFFERENT HOSPITAL, A SAMPLE WAS DRAWN AND TESTED AND THE PLT RESULT WAS SIGNIFICANTLY LOWER. ON 22-APRIL-2024, THE PATIENT CAME TO THE INITIAL HOSPITAL TO COMPLAIN THAT THE HOSPITAL'S EXAMINATION RESULTS WERE INACCURATE AND HAD MISLED HER TO STOP TAKING MEDICATION, RESULTING IN UNCONTROLLED DISEASE PROGRESSION. AFTER RECEIVING THE COMPLAINT, THE LABORATORY DEPARTMENT FOUND THE SPECIMEN THAT WAS EXAMINED ON APRIL 16 AND RE-EXAMINED IT ON APRIL 22, 6 DAYS AFTER ORIGINAL SAMPLE COLLECTION (PER INSTRUCTIONS FOR USE DXH 500, PART C42118AA, THIS IS AN INADEQUATE SAMPLE). IT WAS FOUND THAT THE PLATELET COUNT WAS SIGNIFICANTLY LOWER COMPARED TO THE INITIAL RESULT. THE INVESTIGATION AT THE LABORATORY INITIALLY CONCLUDED THAT THE REASON FOR THIS DISCREPANCY WAS THE AGING AND CLOGGING OF THE INSTRUMENT IN USE FOR NEARLY 5 YEARS WHICH LEAD TO OCCASIONAL SIGNIFICANT OVERESTIMATION OF THE INSTRUMENT'S BACKGROUND BLANK COUNT. THE STAFF OF THE DEPARTMENT APOLOGIZED TO THE PATIENT, REFUNDED THE PATIENT'S EXAMINATION FEE, AND REQUESTED THAT THE BEC FIELD SERVICE ENGINEER (FSE) PERFORM INSTRUMENT MAINTENANCE. AN ATTEMPT WAS MADE TO OBTAIN ADDITIONAL EVENT INFORMATION AND PATIENT RESULTS DATA, BUT THE INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737534 UNICEL DXH 500 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER IRELAND INC TN DXH 500 15099590671242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other