BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 1923443 · Received December 13, 2010

    Report

    Report Number
    1061932-2010-00268
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 15, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS WERE NOT RUN BEFORE AND/OR AFTER THE EVENT. SERVICE AS NOT DISPATCHED FOR THIS EVENT. THE ORIGINAL RUN INCLUDED IS CBC. TO RUN A REFLEX, A DIFFERENT TEST (SUCH AS DIFF OR RETIC) MUST BE ORDERED. THE 2ND SAMPLE IS CDR. IT SHOULD BE IMPOSSIBLE TO ORDER A PREDILUTE AND GET A CDR. THEREFORE, THERE WAS NO MULTIPLICATION - THEY ORDERED CDR. SOFTWARE DEVELOPMENT VERIFIED THAT ON A 1.1.3.1 SYSTEM, IT IS IMPOSSIBLE TO RUN A CDR PANEL ON A PREDILUTED SPECIMEN. BASED ON AVAILABLE INFORMATION; EITHER A CDR WAS RE-FLEXED FROM CBC PANEL AND THEN PREDILUTED THE SPECIMEN, OR THE SPECIMEN WAS PREDILUTED AND THEN ORDERED A CDR. IN BOTH INSTANCES THE PREDILX5 MULTIPLICATION IS NOT POSSIBLE. THE ROOT CAUSE OF THIS EVENT IS USER ERROR.

    Description of Event or Problem · 1

    BECKMAN COULTER INC. (BCI) (B)(6) REPORTED ERRONEOUS LOW CBC RESULTS GENERATED ON UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM FOR A PATIENT SPECIMEN WHEN THE SAMPLE WAS MANUALLY DILUTED AND ANALYZED IN PRE-DILUTED X 5 MODE ON SINGLE-PRESENTATION. THE CBC RESULTS WERE NOT MULTIPLIED BY FIVE AS EXPECTED. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LAB. DATA SUBMITTED SHOWS INITIAL SAMPLE WAS RUN IN CBC MODE. THE RERUN RESULTS WERE ERRONEOUSLY LOW AND WERE RUN IN CDR MODE. NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS INCIDENT.

    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