BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF ANALYZER

    MDR report key: 1052482 · Received May 22, 2008

    Report

    Report Number
    1061932-2008-00032
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC IS RUN ONCE PER DAY AND WAS RUN BEFORE AND AFTER THE EVENT, AND RESULTS WERE WITHIN SPECIFICATIONS. THE SPECIMEN IN QUESTION WAS COLLECTED VIA FINGERSTICK IN A RAM SCIENTIFIC, 125 UL COLLECTION DEVICE AND RUN WITHIN 3 MINUTES OF DRAW. A FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE VERIFIED AND VALIDATED THE INSTRUMENT AND FOUND NO INSTRUMENT RELATED PROBLEMS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT. (B) (4).

    Description of Event or Problem · 1

    A PT WAS SENT TO A HOSP FOLLOWING CBC RESULTS OBTAINED FROM THE COULTER ACT DIFF ANALYZER. THE PT WAS REDRAWN AT THE HOSP AND UPON DATA REVIEW, IT WAS NOTED THAT HEMOGLOBIN (HGB) RESULT OBTAINED FROM THE ACT DIFF ANALYZER WAS LOWER THAN THE HOSPITAL'S RESULT. ACT DIFF ANALYZER HGB RESULT - 11.2G/DL. HOSP HGB RESULT - 12.4G/DL. BASED ON INFO PROVIDED, THERE WAS NO DEATH OR INJURY AND PT TREATMENT WAS NOT IMPACTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA