BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 2 ANALYZER

    MDR report key: 2585778 · Received May 23, 2012

    Report

    Report Number
    1061932-2012-01651
    Event Type
    Malfunction
    Date Received
    May 23, 2012
    Date of Event
    April 24, 2012
    Report Date
    May 1, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED VIA VENIPUNCTURE AND RUN IMMEDIATELY. QC RECOVERING WITHIN ACCEPTABLE RANGE AND NEAR TARGET VALUES ASIDE FROM PLATELETS. THE CUSTOMER INDICATED THAT A DIFFERENT PATIENT SAMPLE, DOCUMENTED IN A SEPARATE MDR (1061932-2012-01672) WAS DEMONSTRATING ERRONEOUS HIGH HEMOGLOBIN (HGB) AND HEMATOCRIT (HCT) RESULTS ON THE SAME INSTRUMENT. BEC FIELD SERVICE ENGINEER WENT ON-SITE AND SERVICED THE INSTRUMENT FOR BOTH REPORTED EVENTS AND DID NOT OBSERVE ANY INSTRUMENT PROBLEMS. HOWEVER, FSE PERFORMED PREVENTIVE MAINTENANCE BY REPLACING THE PROBE, RBC DILUENT FILTERS, WASTE FILTER, VACUUM AIR FILTER, AND MIX CHECK VALVES. FSE ALSO ASSISTED WITH S-CAL CALIBRATION. THE CAUSE OF THE EVENT IS UNKNOWN. PER FSE, THE FLAGGING MAY HAVE BEEN DUE TO PATIENT ABNORMALITY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REGARDING HIGH WBC RESULTS GENERATED BY THEIR COULTER ACT DIFF 2 ANALYZER FOR ONE PATIENT. THE PATIENT INITIAL RUNS FOR WBC WERE HIGH (INITIAL AND RERUN 1), WITHOUT INSTRUMENT GENERATED FLAGS. THE RESULTS WERE CONSIDERED HIGH COMPARED TO THE PATIENT'S HISTORY. BEC DATA REVIEW ALSO INDICATED DISCREPANT RESULTS FOR THE REMAINING CBC PARAMETERS - HIGH RBC, HEMOGLOBIN (HGB), PLATELETS (PLT), HEMATOCRIT (HCT) AND LOW MCV, MCH, AND RDW PARAMETERS. THE CUSTOMER RE-RAN THE PATIENT SAMPLE SEVERAL ADDITIONAL TIMES AND THE LOWER WBC, RBC, HGB, PLT, HCT AND HIGHER MCV, MCH, AND RDW PARAMETERS REPRODUCED WHICH MATCHED THE PATIENT HISTORY (RERUNS 2, 3, 4). INSTRUMENT PRINTOUTS FOR THE PATIENT WERE NOT PROVIDED. PATIENT RESULTS WERE OBTAINED FROM PATIENT SUMMARY REVIEW REPORT. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. 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 DIFF 2 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. ACT DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1