BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF ANALYZER

    MDR report key: 4840569 · Received June 12, 2015

    Report

    Report Number
    1061932-2015-00971
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 3, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON 06/03/2015. THE FSE FOUND ELEVATED RED CELL DISTRIBUTION WIDTH, RDW, RESULTS FOR LOW CONTROL. THE NORMAL AND HIGH CONTROL WERE WITHIN LIMITS. THE ASSAY VALUE FOR THE LOW CONTROL IS 13.7. THE INSTRUMENT RECOVERED VALUES BETWEEN 15.4 - 15.9. THE INSTRUMENT IS WITHIN LIMITS AT 15.4, BUT OUTSIDE LIMITS AT 15.9. HE REPLACED THE RED BLOOD CELL, RBC, BATH AND PERFORMED CALIBRATION WHICH BROUGHT THE ELEVATED RDW RESULTS WITHIN RANGE. THE REPAIRS WERE VERIFIED PER ESTABLISHED SERVICE PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    WHILE FIELD SERVICE ENGINEER (FSE) WAS TROUBLESHOOTING AN UNRELATED EVENT, THE FSE DISCOVERED ELEVATED RED CELL DISTRIBUTION WIDTH, RDW, RESULTS FOR LOW CONTROL OF A COULTER ACT DIFF ANALYZER. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386399 COULTER ACT DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1