BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH500 HEMATOLOGY ANALYZER

    MDR report key: 3083578 · Received April 29, 2013

    Report

    Report Number
    1061932-2013-00682
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE REPLACED THE BLOOD SAMPLING VALVE (BSV) ACTUATOR TO CORRECT THE H/H MISMATCH. THE FSE ALSO FOUND AN AIR LEAK FROM WORN PRIMARY AND SECONDARY ASPIRATION PUMPS, AND REPLACED BOTH PUMPS AS PREVENTIVE MAINTENANCE. PER THE FSE, THE LYSE S III REAGENT WAS ALSO REPLACED TO RESOLVE THE DROP ON HGB RECOVERY. THE FSE SUSPECTED THE REAGENT WAS RECEIVED FROZEN AND MAY HAVE BEEN USED AS SUCH. FAILURE MODE OF THE H/H MISMATCH WAS RELATED TO THE BSV ACTUATOR. THE DROP IN THE HGB RESULTS WAS ATTRIBUTED TO A FROZEN LYSE S III REAGENT, WHICH WOULD MAKE THIS EVENT A USE ERROR. INSTRUCTIONS FOR HANDLING FROZEN REAGENTS ARE DETAILED IN THE PRODUCT IFU. PER IFU INSTRUCTIONS FOR LYSE S III REAGENT PN 8546983; IF PRODUCT HAS BEEN PARTIALLY OR COMPLETELY FROZEN, ALLOW PRODUCT TO WARM TO ROOM TEMPERATURE. MIX PRODUCT BY GENTLE INVERSION PRIOR TO PLACEMENT ON THE INSTRUMENT. INSTALL AND PRIME THE REAGENT AS DIRECTED IN THE INSTRUMENT PRODUCT MANUALS AND/OR ONLINE HELP. VERIFY BACKGROUND COUNTS ARE ACCEPTABLE BEFORE ANALYZING PATIENT SAMPLES. REAGENT INFORMATION: REAGENT: LYSE S III DIFF,1L; PART NUMBER: 8546983; LOT NUMBER: 101515F.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THEY EXPERIENCED TWO OCCASIONS ON THEIR COULTER LH500 HEMATOLOGY ANALYZER WHERE HEMOGLOBIN (HGB) DROPPED ON CONTROLS (QC) FROM BETWEEN 0.5 AND 1.0 GRAMS. THE CUSTOMER ALSO REPORTED OCCASIONAL HEMATOCRIT/HEMOGLOBIN (H/H) MISMATCH ON SAMPLE RESULTS. NO ERRONEOUS RESULTS WERE GENERATED. THE CUSTOMER STOPPED USING THE INSTRUMENT SINCE THE CONTROLS DID NOT PASS VERIFICATION AND BEC FIELD SERVICE (FSE) WAS DISPATCHED TO THE CUSTOMER SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184899 COULTER® LH500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1