BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF 2 ANALYZER

    MDR report key: 1911187 · Received November 30, 2010

    Report

    Report Number
    1061932-2010-00232
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED AS A FINGER STICK. PREVIOUSLY RUN PATIENT SAMPLES WERE RERUN TO CONFIRM BACK TO THE LAST ACCEPTABLE CONTROL RUN. CONTROLS WERE RUN BEFORE THIS INCIDENT AND RECOVERED WITHIN ASSAY RANGE. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND VERIFIED THE INSTRUMENT OPERATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE COULTER AC*T DIFF 2 ANALYZER GENERATED AN ERRONEOUSLY LOW HEMOGLOBIN (HGB) RESULT ON A SINGLE PATIENT SPECIMEN ON INITIAL RUN AND RERUN. THE RERUN HGB RESULTS DID NOT HAVE ANY INSTRUMENT GENERATED FLAGS. ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND THE PATIENT WAS SENT TO THE ER AND REDRAWN WITH A COMPLETE BLOOD COUNT (CBC) PERFORMED THAT RECOVERED A NORMAL HGB VALUE. CORRECTED REPORTS WERE ISSUED. THE RESULTS, PROVIDED BY THE CUSTOMER. THERE WAS NO DEATH, SERIOUS INJURY, OR CHANGE TO PATIENT TREATMENT DURING THIS EVENT.

    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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization