BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 2 HEMATOLOGY ANALYZER

    MDR report key: 3041583 · Received April 8, 2013

    Report

    Report Number
    1061932-2013-00550
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT PROVIDES THE CORRECT "DATE RECEIVED BY MANUFACTURER." THE CORRECT DATE IS (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) INDICATED THAT EITHER NOISE OR A SURGE OCCURRED, AS THE PLATELET (PLT) HISTOGRAM LOOKED VERY ABNORMAL FOR THE AFFECTED PATIENT RESULTS AND NORMAL THEREAFTER FOR THE OTHER PATIENT RESULTS. THE FSE COULD NOT CONFIRM THE REPORTED ISSUE WITH PLATELET, BUT REPLACED TWO SMALL CHECK VALVES FOR DILUENT DELIVERY INTO THE RED BLOOD CELL (RBC) BATH AS PREVENTATIVE MEASURE. THE FSE ALSO REPLACED THE WHITE BLOOD CELL (WBC) BATH AS SOME MICROBIAL GROWTH WAS FOUND INSIDE OF THE APERTURE. THE FSE ALSO REPLACED HEMOGLOBIN (HGB) LAMP AS A PREVENTATIVE MEASURE. THE FSE PERFORMED LATEX CALIBRATION, CLOG DETECTION AND QUALITY CONTROL. THE PATIENT SAMPLE WITH THE REPORTED ERRONEOUS RESULTS WAS ALSO RERUN, AND A NORMAL PLT VALUE AND HISTOGRAM WERE OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE COULTER ACT DIFF 2 HEMATOLOGY ANALYZER GENERATED ERRONEOUSLY ELEVATED PLATELET (PLT) RESULT FOR ONE PATIENT'S SAMPLE. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE DOCTOR. REPEAT TESTING ON THE SAME AND ON AN ALTERNATE INSTRUMENT PRODUCED LOWER PLATELET RESULTS AND THE RESULT FROM THE ALTERNATE INSTRUMENT WAS REPORTED AS CORRECT. THERE WAS NO REPORT OF DEATH, INJURY, OR IMPACT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. REVIEW OF THE DATA SHOWED A HIGH PLT, MPV, RBC, HCT, RDW AND LOW MCV, MCH, MCHC ON THE INITIAL RUN WHEN COMPARED TO RERUN RESULTS FROM THE ALTERNATE INSTRUMENT. THE RESULTS FROM THE INITIAL RUN SHOW THAT THE INSTRUMENT GENERATED FLAGS ON THE PLT AND MPV PARAMETERS ONLY AND THE PLT HISTOGRAM DEMONSTRATED AN ABNORMAL PLT DISTRIBUTION. THE RERUN ON THE SAME INSTRUMENT DID NOT EXHIBIT ERRONEOUS RESULTS WHEN COMPARED TO RERUN ON THE ALTERNATE INSTRUMENT. THE RERUN ON THE ORIGINAL INSTRUMENT GENERATED NON-NUMERIC APERTURE ALERT (XXXXX) FOR THE WBC PARAMETER. NOTE: RBC: RED BLOOD CELL; WBC: WHITE BLOOD CELL; HCT: HEMATOCRIT; MCV: MEAN CORPUSCULAR VOLUME; MCH: MEAN CORPUSCULAR HEMOGLOBIN; MCHC: MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION; RDW: RED CELL DISTRIBUTION WIDTH; PLT: PLATELET MPV: MEAN PLATELET VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143398 COULTER® ACT DIFF 2 HEMATOLOGY ANALYZER DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER ACT DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1