BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 3844200 · Received June 2, 2014

    Report

    Report Number
    1061932-2014-01231
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K120771
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 PERFORMED VARIOUS TROUBLESHOOTING TO RESOLVE THE PLT (PLATELET) BACKGROUND ISSUE, INCLUDING REPLACING AND REROUTING VARIOUS TUBING AND ENSURING TIGHT FITTINGS AND OR CONNECTIONS (FOUND LOOSE) IN THE CBC (COMPLETE BLOOD COUNT) FLOW PATHWAY. THE FSE VERIFIED ELECTRONIC NOISE WITHIN SPECIFICATION. A 10-RUN REPRODUCIBILITY WAS WITHIN SPECIFICATION. THE FSE PRIMED SWEEP FLOW. THE FSE PERFORMED 6 SUCCESSIVE DAILY CHECKS. THE PLT BACKGROUND WAS 2.5 TO 3.0 ((B)(4)). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FAILING DAILY CHECKS FOR THE PLATELET BACKGROUND WHEN USING THE UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM. THE CUSTOMER REPORTED THIS ISSUE HAD BEEN OCCURING SINCE THE RECENT INSTALLATION OF THE INSTRUMENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE INSTRUMENT. THERE WERE NO ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322258 UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1