BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T 5 DIFF ANALYZER

    MDR report key: 1897932 · Received November 12, 2010

    Report

    Report Number
    1061932-2010-00214
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 5, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K030291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS SAMPLED WITHIN 2 HOURS AND STORED AT ROOM TEMPERATURE. CONTROLS WERE RUN BEFORE THIS EVENT AND RECOVERY WAS WITHIN ASSAY LIMITS. THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). SERVICE WAS NOT DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) STATING THAT THE COULTER ACT 5 DIFF ANALYZER GENERATED ERRONEOUSLY HIGH PLATELET RESULTS WITHOUT INSTRUMENT GENERATED FLAGS ON A PATIENT SPECIMEN. THE OPERATOR COMPARED THE HIGH PLATELET RESULTS WITH THE PATIENT'S PREVIOUSLY KNOWN PLATELET RESULTS AND NOTICED THE DISCREPANCY. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE OPERATOR RERAN THE SPECIMEN AND RECOVERED A PLATELET RESULT THAT WAS LOWER AND MORE CONSISTENT WITH THE PATIENT HISTORY WHICH THE CUSTOMER CONSIDERS CORRECT AND THIS RESULT WAS REPORTED OUT OF THE LABORATORY. NO DEATH, SERIOUS INJURY, OR CHANGE TO PATIENT TREATMENT IS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC*T 5 DIFF ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. AC*T 5 DIFF AL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1