BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 INSTRUMENT

    MDR report key: 1999706 · Received February 23, 2011

    Report

    Report Number
    1061932-2011-00097
    Event Type
    Malfunction
    Date Received
    February 23, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 25, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, THE INSTRUMENT HAD A BROKEN WATER TRAP WHICH ALLOWED THE CLENZ REAGENT TO OVERFLOW INTO THE COMPRESSOR THAT WAS REPLACED DURING SERVICING. AS PER PRODUCT 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 THE COULTER LH 500 INSTRUMENT LEAKED COULTER CLENZ REAGENT AFTER THE HMX AUTOLOADER HAD A SOFTWARE LOCK UP. APPROXIMATELY ONE (1) LITER OF CLENZ REAGENT LEAKED ONTO THE COUNTER AND INTO THE INSTRUMENT COMPRESSOR. NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS (EYES, NOSE, OR MOUTH). NO MEDICAL TREATMENT WAS SOUGHT OUT BY THE OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 500 INSTRUMENT AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. LH 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1