BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT 5DIFF CAP PIERCE (CP)

    MDR report key: 3771912 · Received April 25, 2014

    Report

    Report Number
    1061932-2014-00931
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 24, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE EVALUATED THE INSTRUMENT AND RAN MULTIPLE TESTS BUT FOUND NO ISSUES WITH INSTRUMENT PERFORMANCE. THE CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRATIC PLATELET (PLT) RESULTS FOR ONE (1) PATIENT SAMPLE FROM THE COULTER ACT 5DIFF CAP PIERCE (CP). THE CUSTOMER STATED THAT THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE PATIENT'S DOCTOR QUESTIONED THE RESULTS AND REQUESTED FOR THE SAMPLE TO BE REPEATED. THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER PROCEEDED TO RUN THE PATIENT SAMPLE SEVERAL TIMES AND OBTAINED DISCREPANT RESULTS. BECKMAN COULTER REVIEWED THE SUPPLIED DATA WHICH INDICATES THAT THE INSTRUMENT GENERATED ERRATIC RESULTS ON ALL PARAMETERS FOR ONE (1) PATIENT SAMPLE WHICH WAS RUN A TOTAL OF SIX (6) TIMES. THE CUSTOMER HAD ALSO SENT THE SAMPLE TO A REFERENCE LABORATORY FOR REPEAT TESTING. THE COULTER ACT 5DIFF CP APPEARED TO HAVE GENERATED CORRECT RESULTS FOR THREE (3) RUNS, AND ERRONEOUS RESULTS FOR THE OTHER THREE (3) RUNS. THE COMPLETE BLOOD COUNT (CBC) PARAMETERS FOR THE THREE ERRONEOUS RESULTS DIFFER GREATLY WHEN COMPARED TO THE REFERENCE LABORATORY RESULTS WHICH WERE CONSIDERED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250992 COULTER® ACT 5DIFF CAP PIERCE (CP) COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR