BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2840160 · Received November 20, 2012

    Report

    Report Number
    1061932-2012-02724
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 24, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. CONTROLS WERE RUN BEFORE THE EVENT BUT IT IS UNKNOWN IF CONTROLS WERE RUN AFTER THE EVENT. PREVIOUSLY RUN SPECIMENS WERE RERUN BACK TO THE LAST KNOWN ACCEPTABLE CONTROL RUN. THE RAW DATA FILES, FOR THIS EVENT, ARE NO LONGER AVAILABLE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. FAILURE MODE OF THIS EVENT IS UNKNOWN. PER LABELING, BECKMAN COULTER INC. DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN ALL SAMPLES. BECKMAN COULTER SUGGESTS USING ALL AVAILABLE FLAGGING OPTIONS TO OPTIMIZE THE SENSITIVITY OF INSTRUMENT RESULTS. ALL FLAGGING OPTIONS INCLUDE REFERENCE RANGES (H/L), ACTION AND CRITICAL LIMITS, DEFINITIVE FLAGS, SUSPECT FLAGS, PARAMETER CODES, DELTA CHECKS, DECISION RULES AND SYSTEM ALARMS. BECKMAN COULTER RECOMMENDS AVOIDING THE USE OF SINGLE MESSAGES OR OUTPUTS TO SUMMARIZE SPECIMEN RESULTS OR PATIENT CONDITIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) IN REGARDS TO AN ERRONEOUSLY LOW PLATELET (PLT) RESULT GENERATED BY THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM, WITHOUT INSTRUMENT GENERATED FLAGS, FOR A SINGLE PATIENT SPECIMEN. ON THE SAME DAY, THE PATIENT WAS REDRAWN AND TESTED FOR PLT ON A DIFFERENT INSTRUMENT IN THE CUSTOMER LAB AND A SIMILAR LOW PLT RESULT WAS OBTAINED. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. A DECISION WAS MADE TO TRANSFUSE THE PATIENT BASED ON THESE RESULTS WHICH WERE NOT CONFIRMED BY MANUAL COUNTS. MULTIPLE ATTEMPTS, FOR ADDITIONAL INFORMATION, WERE MADE BY BEC CONCERNING THE CURRENT CONDITION OF THE PATIENT; HOWEVER, THIS INFORMATION HAS NOT BEEN OBTAINED. THE RESULTS OBTAINED ON (B)(6) 2012 WERE BELIEVED TO BE ERRONEOUS AFTER THE CUSTOMER OBTAINED ERRONEOUSLY LOW PLT RESULTS FOR THIS PATIENT ON (B)(6) 2012 AFTER TRANSFUSION. THIS REPORT IS COVERING THE EVENT OCCURRED ON (B)(6) 2012, INSTRUMENT S/N (B)(4). MDR #: 1061932-2012-02725 IS BEING SUBMITTED FOR EVENT OCCURRED ON (B)(6) 2012, INSTRUMENT S/N (B)(4). MDR #: 1061932-2012-00443 COVERS THE EVENT OCCURRED ON 10/20/2012 AT THIS CUSTOMER SITE.

    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 65 YR Other