BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2970714 · Received February 20, 2013

    Report

    Report Number
    1061932-2013-00273
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER BLEACHED THE RBC BATH IN AN EFFORT TO TROUBLESHOOT THE ISSUE WITH RBC AND PLT NOT REPRODUCING. THE CUSTOMER IDENTIFIED THAT THE RBC APERTURE VENT CHECK VALVE WAS INSTALLED INCORRECTLY AND WAS CORRECTLY RE-INSTALLED. THE PATIENT SAMPLES WERE RERUN WITHOUT FURTHER ERRORS. FAILURE MODE: LEAK ATTRIBUTED TO THE VENT CHECK VALVE ASSOCIATED WITH THE RBC BATH THAT WAS LIKELY INSTALLED INCORRECTLY BY THE CUSTOMER DURING TROUBLESHOOTING. 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 (BEC) REPORTING THAT LESS THAN 1 ML FLUID FROM THE BATH CAME OUT OF THE RED BLOOD COUNT (RBC) BATH VENT CHECK VALVE DURING THE SAMPLE CYCLE (DURING RINSING) ON THE COULTER LH 750 HEMATOLOGY ANALYZER AFTER TROUBLESHOOTING WITH BEC CUSTOMER TECHNICAL SUPPORT (CTS) FOR RBC AND PLATELET (PLT) RESULTS WERE NOT REPRODUCING WELL. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE SAMPLES WERE EXHIBITING INTERMITTENT CHECK FAILED MESSAGES (OPERATOR-DEFINED) ON PATIENT AND CONTROL RESULTS. THE CUSTOMER BLEACHED THE RBC BATH IN AN EFFORT TO TROUBLESHOOT THE ISSUE WITH RBC AND PLT NOT REPRODUCING. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. INSTRUMENT PRINTOUTS WERE NOT PROVIDED FOR FURTHER EVALUATION OF THE RESULTS AND CORRECT RESULTS WERE NOT PROVIDED. HOWEVER, THE VALUES PROVIDED DID SHOW INCONSISTENCIES IN THE RBC, HEMATOCRIT (HCT), MEAN CORPUSCULAR HEMOGLOBIN (MCH), MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION (MCHC), AND PLT VALUES. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, GOGGLES, AND A LABORATORY COAT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74430 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1