BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT 5DIFF AUTOLOADER

    MDR report key: 2242676 · Received September 10, 2011

    Report

    Report Number
    1061932-2011-01403
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K030291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS FRESH EDTA VENIPUNCTURE 3ML STORED AT ROOM TEMPERATURE. CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT AND WERE WITHIN LIMITS. THE INSTRUMENT WAS PERFORMING WITHIN QUALITY CONTROL SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT. THE FSE REPLACED THE PROBE, NEEDLE CARTRIDGE, PROBE WIPE, DIFF LAMP AND FLOWCELL. THE FSE RAN SEVERAL PATIENT SAMPLES TO VERIFY AND VALIDATE THE SYSTEM. THE INITIAL RUN AND RERUN RESULTS ARE INDICATIVE OF AN INADEQUATELY MIXED SPECIMEN WHEN COMPARED TO THE REDRAWN RESULTS. PER LABELING, COLLECT AND MIX THE SPECIMEN, MIX THE BLOOD SPECIMEN GENTLY AND THOROUGHLY BEFORE ANALYSIS ACCORDING TO THE TUBE MANUFACTURER'S RECOMMENDATIONS AND YOUR LABORATORY'S PROTOCOL.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE COULTER ACT 5DIFF AUTOLOADER GENERATED LOW WHITE BLOOD CELLS (WBC), PLATELETS (PLT), AND HIGH RED BLOOD CELLS (RBC), HEMOGLOBIN (HGB) AND HEMATOCRIT (HCT) RESULTS FOR ONE (1) PATIENT WITH INSTRUMENT GENERATED FLAGS IN CBC/DIFF MODE. PER PROTOCOL, THE CUSTOMER RERAN THE SAME SPECIMEN IN CBC MODE WITH SIMILAR RESULTS BUT WITHOUT INSTRUMENT GENERATED FLAGS. THE HGB & HCT RESULTS WERE FLAGGED HH (ACTION HIGH) ON BOTH RUNS. RERUN RESULTS WERE REPORTED OUT OF THE LAB. BECAUSE OF THE HH FLAGGING, THE SAME PATIENT WAS REDRAWN AND RUN ON A REFERENCE INSTRUMENT WITH RESULTS THAT WERE CONSIDERED CORRECT. THE REDRAWN SAMPLE WAS RUN ON THE COULTER ACT 5DIFF AUTOLOADER IN CBC/DIFF MODE WITH SIMILAR BUT LOWER WBC, RBC, HGB AND RED CELL DISTRIBUTION WIDTH (RDW) RESULTS COMPARED TO THE REFERENCE RESULTS. ALL SAMPLES PROCESSED ON THE COULTER ACT 5DIFF AUTOLOADER WERE RUN IN MANUAL (OPEN VIAL) MODE. ALL SAMPLES RUN BEFORE AND AFTER THE INCIDENT WERE VERIFIED FOLLOWING THE CUSTOMER'S PROTOCOL AND CONSIDERED ACCURATE. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT 5DIFF AUTOLOADER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. ACT 5DIFF NA

    Patients

    Seq Age Sex Outcome Treatment
    1