BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T DIFF 2 ANALYZER

    MDR report key: 3328563 · Received September 5, 2013

    Report

    Report Number
    1061932-2013-01895
    Event Type
    Malfunction
    Date Received
    September 5, 2013
    Date of Event
    August 14, 2013
    Report Date
    August 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE DISCOVERED THAT THE DIFFERENTIAL PARAMETERS OCCASIONALLY FLAGGED PATIENT SAMPLES AND CONTROLS. THE FSE PROCEEDED TO REPLACE THE ANALYZER CARD TO RESOLVE THE FLAGGING ISSUE. THE FSE CONCLUDED THAT THE DISCREPANT LOW RESULTS WERE RELATED TO SAMPLE HANDLING AS THE CUSTOMER STATED THAT THE LABORATORY HAD NEW TECHNICIANS WHO WERE NEW TO USING THE FINGER STICK METHOD AND WERE BEING TRAINED TO CORRECTLY UTILIZE THE FINGER STICKS. RESULTS: FAILURE MODE OF THE EVENT MAY HAVE BEEN ATTRIBUTED TO IMPROPER SAMPLE COLLECTION AND HANDLING, AS WELL AS A DEFECTIVE ANALYZER CARD. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING LOW WHITE BLOOD CELL (WBC) AND PLATELET (PLT) RESULTS FOR A SINGLE FINGER STICK PATIENT SAMPLE FROM THE COULTER AC*T DIFF 2 ANALYZER. THE CUSTOMER STATED THAT THE SAME PATIENT WAS REDRAWN BY VENIPUNCTURE AND RAN AT A DIFFERENT LOCATION (HOSPITAL), AND MUCH HIGHER RESULTS WERE OBTAINED. THE CUSTOMER INDICATED THAT ALL QUALITY CONTROL (QC) RESULTS WERE RECOVERING WITHIN THE ESTABLISHED RANGES AT THE TIME OF THE EVENT. ALTHOUGH THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY, THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. BECKMAN COULTER REVIEWED THE PROVIDED DATA AND NOTED THAT THE AC*T DIFF 2 INSTRUMENT GENERATED LOW WBC, RED BLOOD CELL (RBC), HEMOGLOBIN (HGB), HEMATOCRIT (HCT), AND PLT RESULTS WITH DIFFERENTIAL FLAGGING AND NO INSTRUMENT-GENERATED SUSPECT MESSAGES FOR THE FINGER STICK CAPILLARY METHOD WHEN COMPARED TO THE RESULTS OBTAINED AT THE HOSPITAL ON THE SAME DAY. THE CUSTOMER STATED THAT THE WHOLE BLOOD SAMPLE WAS COLLECTED IN A 125 L EDTA MICROTAINER AND WAS RUN WITHIN 5 MINUTES OF COLLECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440576 COULTER® AC*T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1