BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 ANALYZER

    MDR report key: 1994170 · Received February 16, 2011

    Report

    Report Number
    1061932-2011-00082
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LOQ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CLEANED THE SPILL ACCORDING TO THE DEFINED LABORATORY PROTOCOL. AFTER CLEANING THE CUSTOMER WAS GETTING "AUTO STOP" ALARMS AND STRIPPER PLATE ERRORS. THE CUSTOMER INDICATED THAT THE TUBE WAS NOT OPENED PRIOR TO RUNNING AND THE CASSETTE WAS CORRECTLY PLACED ON THE LOADING DOCK AND ROCKER BED IN THE USUAL MANNER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND INDICATED THAT THE STRIPPER PLATE ASSEMBLY WAS DISASSEMBLED, SO THE FSE CLEANED AND REASSEMBLED IT. THE ALIGNMENT OF THE STRIPPER PLATE WITH SAMPLE TUBE WAS ALSO CHECKED WITH SATISFACTORY RESULTS. MULTIPLE PATIENT SAMPLES WERE RUN WITHOUT ANY ISSUES. THE ROOT CAUSE COULD NOT BE DETERMINED TO DATE FOR THIS EVENT. PER LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT ONE HEMOGARD VACUTAINER PLASTIC TUBE CAP CAME OFF WHILE THE SAMPLE WAS BEING RUN ON THE COULTER LH 750 ANALYZER, CONSEQUENTLY SPILLING BLOOD INSIDE THE INSTRUMENT. THE TUBE WAS IN A CASSETTE ON THE ROCKER BED WHEN THE INCIDENT OCCURRED. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WERE NO REPORTS OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER LOQ BECKMAN COULTER, INC. LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1