BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2233732 · Received September 3, 2011

    Report

    Report Number
    1061932-2011-01360
    Event Type
    Malfunction
    Date Received
    September 3, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND STORAGE INFORMATION WERE NOT PROVIDED. THE CONTROLS WERE RUN PRIOR TO PROCESSING THE SPECIFIC SPECIMEN AND AFTER THE EVENT. ALL RESULTS WERE WITHIN THE SPECIFICATIONS. THE FLAGGING SENSITIVITY SETTINGS WERE [3303], WHERE THE BLASTS, VARIANT LYMPH, IMM NE 1, IMM NE 2, WERE ALL SET AT HIGHEST LEVEL AND IMM NE1 WAS SET TO OFF. RAW DATA ANALYSIS PROVIDED THE FOLLOWING: THE SAMPLE SHOWS A RELATIVELY SMALL AMOUNT OF NEUTROPHILS. THE NEUTROPHIL POPULATION IS TOUCHING THE LYMPH POPULATION. THE PATTERN IS SLIGHTLY ABNORMAL, BUT IT WAS NOT SIGNIFICANT ENOUGH TO TRIGGER THE BLAST FLAGGING RULES. ON (B)(4) 2011, BEC FIELD SERVICE ENGINEER COLLECTED DATA AND VERIFIED THE INSTRUMENT. THE INSTRUMENT WAS PERFORMING WITHIN THE SPECIFICATIONS. ROOT CAUSE FOR THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM GENERATED ERRONEOUS DIFFERENTIAL RESULTS. THE INSTRUMENT DID NOT GENERATE A DIFFERENTIAL SUSPECT BLAST FLAG FOR A LYMPHOMA PATIENT WITH 28% BLASTS CELLS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. MANUAL DIFFERENTIAL TEST SHOWED 28% BLASTS CELLS. CORRECTED DIFFERENTIAL REPORT WAS ISSUED BASED ON THE MANUAL TEST. THE PATIENT RESULTS ARE SHOWN. THERE WAS NO DEATH, INJURY, OR EFFECT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. DXH 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1