BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 8782923 · Received July 11, 2019

    Report

    Report Number
    1061932-2019-01708
    Event Type
    Injury
    Date Received
    July 11, 2019
    Date of Event
    June 12, 2019
    Report Date
    August 23, 2019
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    UDI-DI
    15099590672423
    PMA / PMN Number
    K140911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION AVAILABLE DOES SUGGEST THERE WAS A SERIOUS INJURY IN THE FORM OF AN BONE MARROW DRAW THAT WAS NOT REQUIRED BY ONE PATIENT. THE INFORMATION AVAILABLE DOES SUGGEST THERE WAS A MALFUNCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR THIS EVENT AND THE INVESTIGATION IS STILL ONGOING. THIS REPORT HAS BEEN SUBMITTED FOR THE UNREQUIRED BONE MARROW DRAW, AN UPDATE WILL BE PROVIDED AS NEW INFORMATION BECOMES AVAILABLE. INTERNAL BEC IDENTIFIER. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULT AND CONCLUSION CODES HAVE BEEN UPDATED TO REFLECT CURRENT INFORMATION. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE DXH800 INSTRUMENT AND FOUND NO MALFUNCTIONS OF THE INSTRUMENT. UPON FURTHER DISCUSSION ON (B)(6) 2019 WITH THE LABORATORY DOCTOR, THE INCIDENT DID NOT OCCUR AS A RESULT OF THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM AS ORIGINALLY REPORTED, THE DISCREPANCY OCCURRED AS A RESULT OF CARRYOVER ON THE SLIDE PRODUCED BY THE UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM (REPORTED IN MDR# 1061932-2019-01787). IT WAS CONFIRMED THAT THE RESULTS GENERATED ON THE DXH800 WERE CONSISTENT AND CONSIDERED CORRECT. BEC INTERNAL IDENTIFIER - (B)(4). RELATED EVENTS - (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM HAD GENERATED WBC CARRYOVER AND VARIABLE LYMPH MESSAGES WHILE RUNNING S SAMPLE. THIS PROMPTED A MANUAL SLIDE ASSESSMENT FOR THE PATIENT AND AS A RESULT OF THE SLIDE, THE PATIENT WAS THOUGHT TO HAVE RELAPSED AND A BONE MARROW DRAWING WAS DONE. THE SAMPLE WAS FOR A (B)(6) YEAR OLD FEMALE PATIENT WITH ACUTE MYELOID LEUKEMIA (AML). THE SLIDE REVIEW PROMPTED THE BONE MARROW PROCEDURE. IT WAS CONFIRMED THAT THE PATIENT HAD NOT RELAPSED AS INITIALLY SUSPECTED. THE PATIENT RECOVERED FROM THE PROCEDURE WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577101 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER TN,DXH 800HEMATOLOGY SYSTEM WITH FLOOR STAND 15099590672423

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other