BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3163513 · Received June 11, 2013

    Report

    Report Number
    1061932-2013-01064
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE ALIGNED THE TUBE BOTTOMS FOR BEC CONTROL TUBES AND FOR NORMAL TUBES. THE FSE RAN THE TUBES THROUGH AND ALL WERE PIERCED FINE. THE FSE INDICATED THAT THE ALIGNMENT WAS TOO FAR DOWN INTO TUBE FOR PIERCING BOTTOM OF CALIBRATOR. AFTER THE ALIGNMENT, THE INSTRUMENT WAS PIERCING TO PROPER DEPTH. THE FSE RAN CONTROLS AND DAILY CHECKS AND ALL RESULTS PASSED. THE CUSTOMER WAS SENT A REPLACEMENT CALIBRATOR MATERIAL. FAILURE MODE WAS THAT THE PROBE WAS NOT PROPERLY ALIGNED FOR CALIBRATOR TUBE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE PROBE ON THE UNICEL DXH 800 COULTER ANALYZER PIERCED THROUGH THE BOTTOM OF THE BEC CALIBRATOR TUBE CAUSING A HOLE AND MATERIAL LEAKED INTO THE CASSETTE. THE VOLUME OF THE LEAK WAS LESS THAN 4 ML. THE CUSTOMER INDICATED THAT THEY TRIED TO USE A DIFFERENT TUBE AND THE SAME OCCURRED. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THE OPERATOR WAS WEARING A LABORATORY COAT AND GLOVES AT THE TIME OF THE EVENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY, OR EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263866 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER DXH 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1