BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT 5 DIFF CAP PIERCE (CP)

    MDR report key: 3844211 · Received June 2, 2014

    Report

    Report Number
    1061932-2014-01233
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 15, 2015
    Report Date
    May 15, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND REPLACED THE WBC (WHITE BLOOD CELL) APERTURE TO RESOLVE THE ISSUE. THE SYSTEM PERFORMANCE WAS VERIFIED. THIS MDR IS RELATED TO MDR 1061932-2014-01232, FOR THE SIMILAR EVENT THAT WAS REPORTED ON (B)(6) 2014.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS HIGH WHITE BLOOD CELL (WBC) TEST RESULTS WERE GENERATED FOR PATIENT SAMPLES WHEN USING THE COULTER ACT 5 DIFF CAP PIERCE (CP) ON (B)(6) 2014. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUSLY HIGH WHEN COMPARED TO PREVIOUS TEST RESULTS FOR THE PATIENTS. THE SYSTEM DELTA CHECK MESSAGES THAT WERE GENERATED INDICATED THAT THE CURRENT RESULTS DID NOT CORRESPOND WITH PREVIOUS PATIENT RESULTS. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE INSTRUMENT. THERE WAS NO DEATH NOR INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED TO THIS EVENT AS THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED FOR PATIENTS TESTED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322270 COULTER ACT 5 DIFF CAP PIERCE (CP) COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1