BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T DIFF ANALYZER

    MDR report key: 2368714 · Received December 13, 2011

    Report

    Report Number
    1061932-2011-02634
    Event Type
    Malfunction
    Date Received
    December 13, 2011
    Date of Event
    November 23, 2011
    Report Date
    November 23, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED ON (B)(6) 2011 REPORTING OF ERRONEOUS LOW CELL COUNTS FOR ONE PATIENT SAMPLE GENERATED ON COULTER ACT DIFF ANALYZER. CUSTOMER STATED THAT MOST PARAMETERS WERE FLAGGED LOW, MEAN CELL VOLUME (MCV) HIGH AND RED CELL DISTRIBUTION WIDTH (RDW) HIGH. CUSTOMER ALSO NOTICED A LEAK OF APPROXIMATELY 3-4 ML OF DILUENT AND BLOOD WHICH OVERFLOWED FROM THE BATHS. CUSTOMER DID NOT PROVIDE PRINTOUTS OF THE SAMPLE THAT WAS CYCLING AT THE TIME OF THE INCIDENT. INSTEAD, CUSTOMER CHOSE TO SELECT A SPECIMEN WHICH HAD BEEN RUN PRIOR TO THE LEAK WITH CORRECT RESULTS, RE-RUN IT TO DEMONSTRATE THE PROBLEM AND SUBMIT PRINTOUTS FOR EVALUATION. CUSTOMER NOTED THAT NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND OPERATOR STOPPED USING INSTRUMENT IMMEDIATE SO NO OTHER PATIENT RESULTS WERE AFFECTED. CUSTOMER WAS NOT EXPOSED TO THE LEAK AND NO INJURY OR CHANGE TO PATIENT TREATMENT WAS REPORTED. REVIEW OF THE SUBMITTED PRINTOUTS REVEALS ERRONEOUS LOW VALUES FOR ALL MEASURED COMPLETE BLOOD COUNT (CBC) PARAMETERS: WHITE BLOOD CELL (WBC), RED BLOOD CELL (RBC), HEMOGLOBIN (HGB), MCV, PLATELET COUNT (PLT) AND RDW. INSTRUMENT GENERATED FLAG WAS ALSO PRESENT FOR THE WBC VALUE. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND A HOLE WORN IN THE PERISTALTIC TUBING FOR WASTE/BATH DRAIN. FSE REPLACED THE TUBING AND VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND PERFORMANCE MEET PUBLISHED SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® AC*T DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. AC*T DIFF

    Patients

    Seq Age Sex Outcome Treatment
    1