BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC.T DIFF 2 ANALYZER

    MDR report key: 1022623 · Received March 31, 2008

    Report

    Report Number
    1061932-2008-00017
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 10, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC IS RUN ONCE A DAY AND WAS RUN AFTER THE EVENT WITH GOOD RESULTS. THE INSTRUMENT IS CURRENTLY WORKING WITHIN QC SPECIFICATIONS. PREVIOUSLY RUN PATIENT SAMPLES WERE NOT RERUN TO CONFIRM ACCURACY AND REPRODUCIBILITY. THE SPECIMEN WAS DRAWN VIA VENIPUNCTURE, IN A 3ML BD TUBE. THE ERRONEOUS RESULT WAS FOR A SPECIFIC SAMPLE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE INSPECTED THE INSTRUMENT AND DISCOVERED AN AIR IN THE LYSE PATHWAY. THE FSE REPLACED MANY OF THE HARD TUBING CONNECTOR TUBING IN THE PATHWAY TO ELIMINATE THE AIR. THE FSE THEN VERIFIED THE INSTRUMENT AND REPRODUCIBILITY FAILED HGB. THE FSE CLEANED AND REPLACED SEVERAL HARDWARE COMPONENTS. THE FSE VERIFIED PASSING STARTUP, QC, AND REPRODUCIBILITY. AS OF 2008, THERE HAVE BEEN NO FURTHER REPORTED EVENTS OF DIFFERENT RESULTS BETWEEN INSTRUMENTS FROM THIS LAB. 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 AC.T DIFF INSTRUMENT. A PATIENT SAMPLE WAS TESTED FOR HGB AND A RESULT OF 6.1G/DL WAS OBTAINED. THE RESULT WAS REPORTED OUT OF THE LAB AND A PHYSICIAN REQUESTED THE SAMPLE BE SENT TO A REFERENCE LAB FOR HGB TESTING. THE REFERENCE LAB RESULT RECOVERED AS 11.5 (UNITS UNKNOWN) AND WAS CONSIDERED CORRECT. BASED ON THE AVAILABLE INFORMATION, 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