BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3110268 · Received May 13, 2013

    Report

    Report Number
    1061932-2013-00896
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED THE LYSE RESTRICTOR TUBING, PERFORMED LYSE TIMING AND ADJUSTED THE HGB LAMP VOLTAGE TO RESOLVE THE ISSUE. FAILURE MODE: LYSE RESTRICTOR TUBING. 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 PROTECTIVE EYEWEAR, GLOVES AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    AN INTERNAL CUSTOMER OF BECKMAN COULTER (BEC) REPORTED THAT LESS THAN 1 ML OF LYSE REAGENT LEAKED FROM AN UNKNOWN SOURCE ON THE COULTER LH 750 HEMATOLOGY ANALYZER. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. IT WAS ALSO REPORTED THAT WHITE BLOOD COUNT (WBC) AND HEMOGLOBIN (HGB) WERE HIGH OUT OF RANGE ON QUALITY CONTROL (QC). THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, GOGGLES, AND A LABORATORY COAT AT THE TIME OF THE INCIDENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THERE IS AN EXPOSURE CONTROL / RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. MEDICAL ATTENTION WAS NOT SOUGHT. PATIENT SAMPLES ARE NOT RUN ON THIS INSTRUMENT THEREFORE THERE WAS NO IMPACT TO PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210707 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1