BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3472720 · Received November 15, 2013

    Report

    Report Number
    1061932-2013-02553
    Event Type
    Malfunction
    Date Received
    November 15, 2013
    Date of Event
    October 25, 2013
    Report Date
    October 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND REMOVED THE DRIED CLEANER, AND REPLACED PINCH VALVE PV37. THE PELTIER MODULE WAS REPLACED BECAUSE THE FSE CONFIRMED THE FAN WAS NOT WORKING PROPERLY. DUE TO MULTIPLE LATRON ISSUES, THE FSE REPLACED THE LIGHT SCATTER PREAMP; A LASER AND A FLOW CELL ALIGNMENT WERE PERFORMED. THE FSE PERFORMED A REPRODUCIBILITY TEST TO ENSURE THAT THE INSTRUMENT WAS REPRODUCING PATIENT RESULTS WITH PRECISION. RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. FAILURE MODE WAS IDENTIFIED: FAILURE MODE OF THE CLEANER LEAK WAS THE BROKEN PINCH VALVE PV37. THE PELTIER MODULE WAS REPLACED DUE TO A NON-WORKING FAN, AND THE LATRON ISSUES WERE RESOLVED BY REPLACEMENT OF THE LIGHT SCATTER PREAMP. NO ERRONEOUS RESULTS WERE GENERATED. A FAILURE RELATED TO PV37 IS LIKELY TO IMPACT CBC/DIFFERENTIAL RESULTS DURING MANUAL ASPIRATION DUE TO CARRYOVER CAUSED BY INSUFFICIENT PROBE BACKWASHING. A CHARACTERIZED FAILURE ASSOCIATED WITH A PELTIER MODULE MALFUNCTION IS IMPROPER SAMPLE/ ERYTHROLYSE DELIVERY TO THE DIFF MIXING CHAMBER FOR DIFFERENTIAL ANALYSIS. DIFFERENTIAL RESULTS ARE IMPACTED DUE TO LIGHT SCATTER PREAMP MALFUNCTIONS. EVALUATION OF PRODUCT LABELING: 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 IS NOT LIMITED TO PROTECTIVE EYEWEAR, GLOVES AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAK WHEN USING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE CUSTOMER REPORTED PINCH VALVE PV37 WAS BROKEN ON THE LH500 AND NEEDED REPLACEMENT. AFTER ARRIVING ON SITE ON (B)(6) 2013, THE FSE DISCOVERED THAT LH CLEANER SPRAYED AND DRIED UP ON THE RIGHT SIDE DOOR AND ON THE INTERIOR OF THE INSTRUMENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT OF GLOVES AND LAB COAT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THERE WERE NO ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594561 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1