BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX CAP PIERCE HEMATOLOGY ANALYZER

    MDR report key: 1822718 · Received September 1, 2010

    Report

    Report Number
    1061932-2010-00133
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 4, 2010
    Report Date
    September 1, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN 4ML VACUTAINER TUBE AND WAS SAMPLED IN AUTOMATIC MODE WITHIN 30 MIN OF COLLECTION. QC (QUALITY CONTROLS) WERE RUN BEFORE AND AFTER THE INCIDENT AND WERE WITHIN ASSAY LIMITS. THERE HAVE BEEN NO ISSUES WITH CONTROLS DURING THIS PERIOD. 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 ERRONEOUSLY LOW NEUTROPHIL (NE) AND HIGH LYMPHOCYTE (LY) RESULTS GENERATED BY THE COULTER HMX CAP PIERCE HEMATOLOGY ANALYZER WHEN COMPARING THE RESULTS FROM TWO DIFFERENT REFERENCE LABS. RESULTS WERE REPORTED OUTSIDE THE LAB AND THE PATIENT WAS TREATED WITH IMMUNE BOOSTERS. CUSTOMER OBTAINED NORMAL DIFFERENTIALS ON THE PATIENT UP UNTIL (B)(6) 2010. NO DEATH OR SERIOUS INJURY WAS 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1