BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC *T DIFF 2 ANALYZER

    MDR report key: 3100559 · Received May 8, 2013

    Report

    Report Number
    1061932-2013-00766
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ASSISTED THE OPERATOR IN RESOLVING THE ISSUE BY PHONE. THE OPERATOR REPORTED TO THE FSE THAT THEY FOUND THAT A VACUUM LINE GOING INTO WASTE CHAMBER HAD CREASED. THE OPERATOR WAS INSTRUCTED TO REPOSITION THE VACUUM LINE, RESOLVING THE LEAK ISSUES. THE CUSTOMER ALSO REPORTED ISSUES WITH DIFFERENTIAL CONTROL RESULTS, WHICH THE FSE ATTRIBUTED TO POSSIBLE DEGRADED CONTROLS AND A NEW SET OF CONTROLS HAVE BEEN ORDERED. THE CUSTOMER WAS CONTACTED ON (B)(4) /2013 AND REPORTED THAT THE PREVIOUS CONTROLS HAD GENERATED VOTEOUTS ON DIFFERENTIAL CONTROLS THIS INDICATES THAT THERE WAS NO INSTRUMENT MALFUNCTION. THE NEW CONTROLS WERE RECEIVED BY THE CUSTOMER AND GENERATED RESULTS THAT WERE WITHIN SPECIFICATIONS. FAILURE MODE WAS RELATED TO A CREASE IN THE VACUUM LINE CONNECTED TO THE WASTE CHAMBER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER THAT THERE WAS A REAGENT FLUID LEAK OF APPROXIMATELY 3 ML FROM THE COULTER AC T DIFF 2 ANALYZER WHILE RUNNING CONTROLS. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. 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, GLOVES AND PROTECTIVE EYEWEAR 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
    200918 COULTER® AC *T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1