BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3122408 · Received May 21, 2013

    Report

    Report Number
    1061932-2013-00876
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. THE FSE REPLACED THE FAULTY PROBE BLOOD DETECTOR, RESOLVING THE ASPIRATION ERRORS ISSUE. BASED ON AVAILABLE INFORMATION, THE CUSTOMER HAD INITIALLY REPORTED TO THE CUSTOMER TECHNICAL SUPPORT (CTS) THAT THE DXH 800 SOFTWARE WOULD NOT REBOOT AFTER TWO HOURS. THE FSE REPORTED ON (B)(4) 2013 THAT THE CUSTOMER HAD NOT REPORTED THIS ISSUE DURING HIS VISIT AND MAY HAVE RESOLVED IT BEFORE HIS ARRIVAL. THE CUSTOMER WAS CONTACTED AND REPORTED THAT THE SYSTEM REBOOT WAS SUCCESSFUL PRIOR TO THE FSE ARRIVAL. FAILURE MODE WAS RELATED TO THE FAULTY PROBE BLOOD DETECTOR. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THERE WERE ASPIRATION ERROR MESSAGES ALONG WITH P FLAGS (SPECIFIC ASPIRATION ERRORS) ON PATIENT RESULTS GENERATED BY THE UNICEL DXH 800 COULTER INSTRUMENT. THE CUSTOMER REPORTED THAT THE INSTRUMENT WAS TAKEN OUT OF SERVICE WHEN THE ASPIRATION ERRORS WERE OBSERVED AND NO PATIENT RESULTS WITH ASSOCIATED ERRORS WERE REPORTED OUT OF THE LABORATORY. IT IS UNKNOWN HOW MANY PATIENT RESULTS WERE IMPACTED. THE AFFECTED PATIENT RESULTS HAVE BEEN REQUESTED, HOWEVER, THEY HAVE NOT BEEN PROVIDED. THERE WAS NO DEATH NOR INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED TO THIS EVENT. TWO BLOOD DETECTORS MONITOR THE ASPIRATION LINE DURING ASPIRATION, DISPENSING AND CLEANING. P-FLAGS (SPECIFIC ASPIRATION ERRORS) ARE GENERATED WHEN THERE IS PARTIAL ASPIRATION DETECTED DURING SAMPLE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223731 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER DXH 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1