BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC T 5DIFF AL ANALYZER

    MDR report key: 3230402 · Received July 16, 2013

    Report

    Report Number
    1061932-2013-01471
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K030291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER TO BLEACH THE FIX LINE AND RERUN CONTROLS, BUT THE CUSTOMER CALLED BACK AND REPORTED THAT THE ISSUE WAS RECURRING AND THAT THERE WAS A LEAK IDENTIFIED. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013 TO EVALUATE THE ANALYZER. THE FSE INSPECTED THE INSTRUMENT AND CONFIRMED THE LEAK WHICH WAS RESOLVED BY REBUILDING NEEDLE CARRIAGE ASSEMBLY. WHILE ON SITE, THE FSE ALSO REPLACED REAGENT AND DIFFERENTIAL SYRINGES IN AN EFFORT TO RESOLVE THE QUALITY CONTROL (QC) ISSUES, AND ORDERED PARTS FOR RETURN VISIT. HOWEVER, THE QC ISSUES WERE NOT RESOLVED AND THE FSE RETURNED TO THE CUSTOMER'S LABORATORY ON (B)(4) 2013 AND REPLACED AN OPTICAL BENCH, RESOLVING THE QC PROBLEM. THE FSE ALSO REPLACED BANK OF 12 SOLENOIDS AND REAGENT SYRINGES AS PART OF INCIDENTAL MAINTENANCE. ONE FAILURE MODE WAS RELATED TO THE NEEDLE CARRIAGE ASSEMBLY AND ANOTHER FAILURE MODE WAS ATTRIBUTED TO THE OPTICAL BENCH. BECKMAN COULTER INTERNAL NUMBER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THERE WAS A FLUID LEAK OF APPROXIMATELY 2 CC FROM THE COULTER AC T 5DIFF AL ANALYZER. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER ALSO REPORTED HIGH AND LOW FLAGGING ON QUALITY CONTROL (QC) FOR NEUTROPHIL AND LYMPHOCYTE PARAMETERS. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THE OPERATOR WAS WEARING A LABORATORY COAT, PROTECTIVE EYEWEAR AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE ASSOCIATED 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
    329414 COULTER® AC T 5DIFF AL ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER ACT 5DIFF AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1