BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER ¿ COULTER ® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2242295 · Received September 10, 2011

    Report

    Report Number
    1061932-2011-01437
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, A FIELD SERVICE ENGINEER (FSE) FOUND RINSE CUP BROKEN. REPLACED RINSE CUP, RAN START UP AND SEVERAL PROBE WIPE TESTS. NO ERRORS OR DEFECTS NOTED. ROOT CAUSE IS UNKNOWN. PER LABELING, BECKMAN COULTER URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IS NOT LIMITED TO, WEARING PROTECTIVE EYE WEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS INSTRUMENT OR ANY OTHER AUTOMATED LABORATORY ANALYZER. BEC INTERNAL IDENTIFICATION NUMBER IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT THAT THE BACKWASH CUP BROK IN HALF THE DAY AFTER MOD WAS INSTALLED AND WHOLE BLOOD DILUTE MIXTURE LEAKED. THE MOD RELEASED AN IMPROVED REVISION OF THE PROBE WIPE ASSEMBLY. WHOLE BLOOD DILUENT MIXTURE WAS LEAKING. THE CUSTOMER WAS WEARING HIS PPE. NO CONTACT TO MUCOUS MEMBRANE OR BROKEN SKIN. NO ONE SOUGHT MEDICAL ATTENTION. NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS INCIDENT. IT IS UNKNOWN IF THERE IS AN EXPOSURE CONTROL OR RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER ¿ COULTER ® LH 750 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. LH750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1