BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER¿ COULTER® LH 750 HEMATOLOGY

    MDR report key: 2230305 · Received September 1, 2011

    Report

    Report Number
    1061932-2011-01329
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    July 31, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND STORAGE INFORMATION WAS NOT PROVIDED. THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). CONTROLS WERE RUN BEFORE AND AFTER THIS EVENT AND WERE WITHIN ACCEPTABLE RANGES. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE BLOOD SAMPLING VALVE (BSV - LINES 207). THE FSE ALSO REPLACED THE RETIC HEATER. THE FSE VERIFIED INSTRUMENT OPERATION PRIOR TO RETURNING IT INTO SERVICE. THE ROOT CAUSE FOR THIS EVENT MAY BE ATTRIBUTED TO THE HARDWARE THAT WAS REPLACED DURING SUBSEQUENT INSTRUMENT SERVICING FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING ERRONEOUS COMPLETE BLOOD COUNT (CBC) RESULTS (ALL PARAMETERS) THAT WERE GENERATED BY THE BECKMAN COULTER COULTER LH 750 HEMATOLOGY ANALYZER FOR TWO (2) PATIENTS. BOTH PATIENT SAMPLES HAD NO INSTRUMENT FLAGS GENERATED ON THE ERRONEOUS RESULTS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. PER THE CUSTOMER, THEY NOTICED THAT CONTROL RECOVERY DROPPING AFTER THREE PIERCING AND PERFORMED REPRODUCIBILITY TESTING, WHICH FAILED. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN THE ATTACHMENT SECTION OF THIS REPORT. THERE WAS NO DEATH, INJURY, OR AFFECT TO PATIENT TREATMENT REPORTED FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1