BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC T 5DIFF AL ANALYZER

    MDR report key: 3173832 · Received June 17, 2013

    Report

    Report Number
    1061932-2013-01112
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K030291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND CONFIRMED THE HEMOGLOBIN (HGB) LYSE LEAKED FROM THE HGB REAGENT SYRINGE. THE FSE REPLACED THE HGB REAGENT SYRINGE ASSEMBLY, RESOLVING THE REPORTED ISSUE. THE FSE PRIMED ALL REAGENTS, RAN A STARTUP, AND LATEX CHECKS, RAN ALL QUALITY CONTROL (QC) AND PATIENT SAMPLES. THE FSE VERIFIED THE SYSTEM WAS OPERATIONAL. THE FAILURE MODE IDENTIFIED WAS RELATED TO THE HGB REAGENT SYRINGE ASSEMBLY WHICH NEEDED REPLACEMENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) A LEAK OF 200 ML OF HEMOGLOBIN (HGB) LYSE REAGENT WHILE THE COULTER AC T 5DIFF AL ANALYZER WAS IN SHUTDOWN. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING GLOVES AND A LABORATORY COAT AT THE TIME OF THE INCIDENT AND VERIFIED THAT NO LINES WERE DISCONNECTED. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. NO DEATH OR INJURY IS ATTRIBUTED TO THIS EVENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273516 COULTER® AC T 5DIFF AL ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER ACT 5DIFF AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1