BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 755 ANALYZER

    MDR report key: 2042146 · Received April 6, 2011

    Report

    Report Number
    1061932-2011-00238
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 2, 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
    JA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND STORAGE INFORMATION WERE NOT PROVIDED FOR THIS INVESTIGATION. CONTROLS WERE RUN BEFORE AND AFTER THE EVENT. THE UNIT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS. RAW DATA ANALYSIS REVEALED THAT THE RAW COUNT RATE FOR RUN 1 IS SIGNIFICANTLY HIGHER THAN RUN 2. THE DIFFERENCE IN THE RAW COUNTS IS DIRECTLY RELATED TO THE DIFFERENCES IN THE WBC RESULTS. MOREOVER, THE RAW COUNT RATE TRENDS DOWN WITH COLLECTION TIME FOR RUN 1 WHILE IT REMAINED FLAT FOR RUN 2. A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE FOLLOWING COMPONENTS: VL3NO TUBE, SOL21, CHECK VALVE, AND VL10. FSE STATED UP VERIFICATION PASSES. RAN PATIENT SPECIMENS FOR SYSTEM VERIFICATION PURPOSES. ROOT CAUSE IS MOST LIKELY ATTRIBUTED TO THE PARTS THAT WERE REPLACED FOR THE SYSTEM DILUTER DURING THE INSTRUMENT SERVICING PERFORMED SUBSEQUENT TO THIS CF EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY HIGH WBC RESULT WITH NO INSTRUMENT GENERATED FLAGS WHEN COMPARED TO THE REPEAT RUN ON THE COUTLER LH 755 INSTRUMENT. THE REPEAT RUN WAS CONSISTENT WITH THE LOWER WBC OBTAINED BY MANUAL COUNT WHICH THE LAB CONSIDERS CORRECT. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 755 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER LOQ BECKMAN COULTER, INC. LH 755 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1