BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3132378 · Received May 29, 2013

    Report

    Report Number
    1061932-2013-00914
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE INSPECTED THE INSTRUMENT AND FOUND THAT THE ELECTRODE ON THE RED BLOOD COUNT (RBC) BATH WAS FAULTY. THE FSE REPLACED THE RBC BATH AS WELL AS CLEARED BLOCKAGE FROM THE SWEEP FLOW WHICH RESOLVED THE HIGH PLATELET (PLT) COUNTS ON THE LOW AND HIGH 6C CONTROLS. FOLLOWING THE REPAIRS, DAILY CHECKS AND QUALITY CONTROL (QC) PASSED VERIFICATION AND THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. HOWEVER, ON THE NEXT DAY THE PLT BACKGROUNDS WERE HIGH. THE FSE RETURNED TO THE CUSTOMER'S LABORATORY ON 04/30/2013 AND REPLACED THE RBC BATH AGAIN TO CORRECT THE ISSUE. SERVICE ACTIVITY WAS PERFORMED AND WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. FAILURE MODE WAS RELATED TO A FAULTY ELECTRODE ON THE RBC BATH AND A BLOCKAGE IN THE SWEEP FLOW LINE. THE INSTRUMENT PERFORMED AS EXPECTED FLAGGING PLTS ON THE LOW AND HIGH 6C CONTROLS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT PLATELET (PLT) COUNTS WERE HIGH ON THE 6C LOW AND HIGH CONTROLS ON THE UNICEL DXH 800 COULTER INSTRUMENT. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. NO DEATH OR INJURY IS ATTRIBUTED TO THIS EVENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234824 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. DXH 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1