BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC.T DIFF 2 ANALYZER

    MDR report key: 1022620 · Received March 31, 2008

    Report

    Report Number
    1061932-2008-00019
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 31, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS RUN TWICE BEFORE THE EVENT AND RESULTS WERE WITHIN LIMITS. A PREVIOUSLY RUN PATIENT SAMPLE WAS RUN BACK TO THE LAST ACCEPTABLE QC RUN TO CONFIRM ACCURACY. A REPRODUCIBILITY STUDY WAS PERFORMED USING THE SAME PATIENT SAMPLE AND RESULTS PASSED. THE SPECIMEN WAS COLLECTED IN A GREINER VACUETTE K3 EDTA TUBE. THE SAMPLE WAS STORED ON A ROCKER AND WAS 30 MINUTES OLD. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE VERIFIED AND VALIDATED THE INSTRUMENT AND NO PROBLEMS WERE FOUND. PER FSE, THE CUSTOMER WAS USING GLASS K3 EDTA TUBES AND RECENTLY THEY SWITCHED TO THE GREINER VACUETTE K3 EDTA PLASTIC TUBES. THE FSE ESTABLISHED AN ACTION PLAN WHERE THE CUSTOMER WILL RUN PATIENT SAMPLES IN DUPLICATE AND THE FSE WILL PERIODICALLY MONITOR. A CLEAR ROOT CAUSE OF THIS EVENT IS UNKNOWN. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING AN ERRONEOUSLY LOW HEMOGLOBIN (HGB) RESULT GENERATED BY THE COULTER ACT. DIFF INSTRUMENT. A PATIENT SAMPLE WAS TESTED FOR HGB AND A RESULT OF 16.6G/DL WAS OBTAINED. DUE TO DIFFERENTIAL FLAGS THE PATIENT SAMPLE WAS RE-MIXED AND RERUN FOR HGB. THE REPEATED RESULT WAS 17.6G/DL. THE SAMPLE WAS RE-TESTED SEVERAL TIMES MORE AND HGB RESULTS WERE HIGHER AND NO FLAGS WERE GENERATED. ADDITIONAL RERUN DATA PRINTOUTS WERE NOT PROVIDED. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LAB. RERUN RESULTS WERE CONSIDERED CORRECT AND AN AMENDED REPORT WAS FILED. BASED ON INFORMATION PROVIDED, THERE WAS NO AFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC.T DIFF 2 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. AC.T DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA