BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX CAP PIERCE HEMATOLOGY ANALYZER

    MDR report key: 1961532 · Received January 14, 2011

    Report

    Report Number
    1061932-2011-00033
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS RUN BEFORE THE EVENT AND RECOVERED WITHIN ASSAY LIMITS. PREVIOUSLY RUN PATIENT SAMPLES WERE RERUN TO CONFIRM ACCURATE BACK TO THE LAST ACCEPTABLE CONTROL RUN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE FOUND THE PAK LYSE AND PAK PRESERVE PUMP VOLUMES HIGH AND ADJUSTED DOWN TO SPECIFICATIONS. THE FSE ALSO LOWERED THE AIR PUMP VOLUME, REPLACED THE LOWER SHEATH RESTRICTOR AND PERFORMED REPRODUCIBILITY AND VERIFIED THE INSTRUMENT OPERATION. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ERRONEOUSLY LOW RESULT FOR LYMPHOCYTES (LY) AND AN ERRONEOUSLY HIGH RESULT FOR NEUTROPHILS (NE) DIFFERENTIAL PARAMETERS GENERATED BY THE COULTER HMX CAP PIERCE HEMATOLOGY ANALYZER FOR ONE PATIENT. THE SAME SPECIMEN WAS RERUN ON A DIFFERENT INSTRUMENT WHICH GENERATED INSTRUMENT DIFFERENTIAL FLAGS. CUSTOMER PERFORMED A MANUAL DIFFERENTIAL AND OBTAINED RESULTS WERE DIFFERENT COMPARING TO THE HMX RESULTS. THESE RESULTS WERE REPORTED OUT OF THE LAB. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. NO CHANGE TO PATIENT TREATMENT IS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX CAP PIERCE HEMATOLOGY ANALYZER HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. HMX CAP PIERCER

    Patients

    Seq Age Sex Outcome Treatment
    1