BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF ANALYZER

    MDR report key: 3892562 · Received June 24, 2014

    Report

    Report Number
    1061932-2014-01463
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND IDENTIFIED A HEMOGLOBIN (HGB) FAILURE AND REPLACED THE HGB LAMP. HE ALSO STATED THAT HE REPLACED DILUENT FILTERS, RBC (RED BLOOD CELL) FILTERS AND AIR FILTER. TWO PARAMETERS, RBC AND PLATELET COUNTS WERE FAILING THE START-UP PROCEDURE. HE REPLACED VACUUM CHAMBER TO RESOLVE THE PLATELET ISSUE. THE SYSTEM PERFORMANCE WAS VERIFIED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TEST RESULTS FOR HEMOGLOBIN WERE NOT GENERATED FOR PATIENT SAMPLES WHEN USING THE COULTER ACT DIFF ANALYZER. ERROR MESSAGES FOR "HEMOGLOBIN VOLTAGE FAILURE" WERE GENERATED BY THE INSTRUMENT DURING THIS EVENT. 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 USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368745 COULTER ACT DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1