BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT 5 DIFF CAP PIERCE (CP)

    MDR report key: 2951057 · Received February 8, 2013

    Report

    Report Number
    1061932-2013-00126
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND MULTIPLE PROBLEMS WITH THE ASPIRATION PROBE AND A SHORT PROBE RINSE LINE. FSE REPLACED AND ALIGNED ASPIRATION PROBE AND REPLACED PROBE RINSE LINE WHICH RESOLVED THE ISSUE. THE CAUSE OF THIS EVENT MAY BE ATTRIBUTED TO THE ASPIRATION PROBE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REGARDING ERRATIC RBC, HEMATOCRIT (HCT) AND PLATELET (PLT) RESULTS GENERATED BY THEIR COULTER ACT 5 DIFF ANALYZER FOR FOUR PATIENTS. THE CUSTOMER CONSIDERED THE RESULTS ERRONEOUS BECAUSE THEY WERE NOT REPRODUCIBLE AND DID NOT MATCH THE PATIENTS' CLINICAL PROFILE. THE SAMPLES WERE RERUN ON A REFERENCE INSTRUMENT WHICH THE CUSTOMER CONSIDERS CORRECT. BEC REVIEW OF THE CUSTOMER SUPPLIED DATA INDICATED ON THE INITIAL RUN FOR SAMPLE #1 THAT THE INSTRUMENT GENERATED LOWER RBC, HCT, MCV, MCH, MCHC, AND RDW WITH NO INSTRUMENT GENERATED FLAGS. FOR THE INITIAL RUN ON SAMPLE #2, THE INSTRUMENT GENERATED HIGHER PLT WITH NO INSTRUMENT GENERATED FLAGS. FOR INITIAL RUN ON SAMPLE #3, THE INSTRUMENT GENERATED LOWER RDW AND HCT AND HIGHER PLT WITH NO INSTRUMENT GENERATED FLAGS. FOR INITIAL RUN ON SAMPLE 4, THE INSTRUMENT GENERATED LOWER RDW AND HIGHER PLT RESULTS WITH NO INSTRUMENT GENERATED FLAGS. THE RERUN RESULTS FOR ALL FOUR SAMPLES SHOWED INSTRUMENT GENERATED MESSAGES OR V(VOTE OUT) FLAGS EXCEPT FOR PLT ON SAMPLE#1 AND SAMPLE#2 WHICH HAD HIGH WBC RESULTS, SAMPLE #3 RERUN GENERATED LOW MCH, RDW RESULTS AND FOR SAMPLE #4 WHICH HAD HIGH PLT RESULTS ALL WITHOUT INSTRUMENT GENERATED FLAGS. THE INSTRUMENT ALSO GENERATED IMM ERRORS WHICH INDICATED A PROBLEM WITH THE DIFFERENTIAL PORTION OF THE BLOOD COUNT. THE CUSTOMER DID NOT CONSIDER THE DIFFERENTIAL RESULTS AS ERRONEOUS AND MANUAL DIFFERENTIAL RESULTS WERE REQUESTED BUT WERE NOT RECEIVED. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO CHANGE TO OR IMPACT ON PATIENT TREATMENT AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53958 COULTER® ACT 5 DIFF CAP PIERCE (CP) AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER ACT 5 DIFF CP NA

    Patients

    Seq Age Sex Outcome Treatment
    1