BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2339899 · Received November 17, 2011

    Report

    Report Number
    1061932-2011-02274
    Event Type
    Malfunction
    Date Received
    November 17, 2011
    Date of Event
    October 19, 2011
    Report Date
    October 19, 2011
    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
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE DRAWN IN SARSTEDT MONOVETTE SPECIMEN COLLECTION TUBES. PER THE CUSTOMER COMPLAINT RECORD, THIS INSTRUMENT IS MAINTAINED BY A THIRD PARTY DISTRIBUTOR (B)(4) (CUSTOMER SITE) IN (B)(4). PER THE CUSTOMER, THIS INSTRUMENT IS CURRENTLY ON DEMO/EVALUATION. THE PROBE PUSHES THE SEPTUM OF THE TUBE CAP INTO THE TUBE DESPITE PERFECT PROBE ALIGNMENT. THE ASPIRATION PROBE WAS REPLACED WITH THE SHARPEST ONE IN STOCK, BUT THE PROBLEM PERSISTED. THE FINAL SOLUTION THAT RESOLVED THE PROBLEM WAS TO SHARPEN THE PROBE. BEC TECHNICAL SUPPORT INFORMED THE DISTRIBUTOR THAT THIS METHOD OF RESOLUTION IS NOT A BEC AUTHORIZED MODIFICATION AND INSTRUCTED THEM TO REPLACE THE MODIFIED PROBE WITH A NEW PROBE. PER LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM'S ASPIRATION PROBE PUSHED THE CAPS INSIDE OF THE TUBES (SARSTEDT COLLECTION) CAUSING A LEAKAGE OF BLOOD AND PLATELET CONCENTRATE. THE CUSTOMER WAS WEARING A LAB COAT WITH NO GLOVES OR FACE PROTECTION AT THE TIME OF THE EVENT. THE OPERATOR PUT ON GLOVES TO CLEAN THE SPILL. THERE WAS NO EXPOSURE TO THE CUSTOMER. THERE WAS NO CONTACT TO MUCOUS MEMBRANE OR OPEN WOUNDS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO AFFECT TO PATIENT RESULTS.

    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