BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 1900787 · Received November 16, 2010

    Report

    Report Number
    1061932-2010-00215
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 18, 2010
    Report Date
    November 16, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS WERE RUN BEFORE AND AFTER THIS EVENT AND RECOVERED WITHIN ASSAY LIMITS. THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). BCI SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE ROOT CAUSE IS BASED ON THE RAW DATA ANALYSIS THAT SHOWS ABNORMAL SAMPLE PATTERNS, BUT THEY ARE NOT SIGNIFICANT ENOUGH FOR THE ALGORITHM TO SET BLAST FLAGS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) STATING THAT THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM DID NOT FLAG FOR BLASTS ON TWO PATIENT SPECIMENS WITHOUT INSTRUMENT GENERATED DIFFERENTIAL FLAGS. THE FIRST PATIENT SPECIMEN HAD A MANUAL DIFFERENTIAL REQUESTED WITH THE COMPLETE BLOOD COUNT (CBC) AND THE MANUAL RESULTS WERE REPORTED OUT. BLAST CELLS WERE REPORTED BY THE MANUAL DIFFERENTIAL. THE SECOND SPECIMEN'S AUTOMATED DIFFERENTIAL WAS REPORTED OUT; THE PHYSICIAN QUESTIONED THE RESULTS AND ORDERED A MANUAL DIFFERENTIAL. BLAST CELLS WERE REPORTED FROM THE MANUAL DIFFERENTIAL. A CORRECTED REPORT WAS SENT OUT FOR THE SECOND SPECIMEN. THERE WAS NO DEATH, SERIOUS INJURY, OR CHANGE 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 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. DXH 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1