BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 2 ANALYZER

    MDR report key: 2120819 · Received June 11, 2011

    Report

    Report Number
    1061932-2011-00614
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 11, 2011
    Manufacturer
    BECKMAN COULTER INC
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN A 4ML BD TUBE AND WAS PLACED ON A ROCKER FOR ONLY A FEW MINUTES PRIOR TO ANALYSIS. THE CONTROLS WERE RUN BEFORE AND AFTER THE REPORTED EVENT AND WERE WITHIN SPECIFICATION. CURRENTLY, THE INSTRUMENT IS PERFORMING WITHIN QC SPECIFICATION. THE FSE FOUND THE HGB GAIN TOO HIGH. FSE REPLACED THE HGB LAMP & LENS AND THE GAIN WAS ADJUSTED. FSE NOTICED BUBBLES IN THE LYSE DELIVERY PATH, THE FMI (FLUID METERING INDEX) PUMP WAS REPLACED. THE ROOT CAUSE FOR THE LOW HGB RESULTS CAN BE ATTRIBUTED TO THE HARDWARE REPLACED AND ADJUSTMENTS MADE BY THE FSE DURING SUBSEQUENT INSTRUMENT SERVICING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT ERRONEOUS LOW HGB RESULT GENERATED BY THE ACT DIFF 2 INSTRUMENT FOR ONE PATIENT SAMPLE WITH NO FLAGS WHEN COMPARED TO THE SAME SAMPLE RERUN AT THE REFERENCE LAB THAT WAS CONSIDERED CORRECT. PATIENT RESULTS ARE PROVIDED. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT DIFF 2 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC ACT DIFF 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1