BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2211030 · Received August 14, 2011

    Report

    Report Number
    1061932-2011-01176
    Event Type
    Malfunction
    Date Received
    August 14, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PEDIATRIC SAMPLE FILLED TO THE PROPER LEVEL. UNIT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. CONTROLS WERE RUN BEFORE THE INCIDENT AND RECOVERED WITHIN RANGE. NO SERVICE WAS DONE AS CONTROLS ARE WITHIN SPEC AND REPRODUCIBILITY ALSO PASSED. ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) IN REGARDS TO ERRONEOUS HIGH RBC AND LOW HGB RESULTS (AND MCH/MCHC) ON TWO PATIENT SAMPLES WITH INSTRUMENT GENERATED ABNORMAL RBC POP MESSAGES AND ANALYZED IN SECONDARY MODE. AN UNDILUTED PEDIATRIC SAMPLE WAS RUN 3 TIMES ON THE HMX AL AND GENERATED HIGH RBC AND LOW HGB (AND MCH / MCHC). THE SECOND PATIENT WAS AN ADULT WITH ERRONEOUS HIGH RBC AND LOW HGB RESULTS. AN OBSERVATION OF BLOOD SMEAR THE CUSTOMER WAS ABLE TO SEE THAT EACH SAMPLE WAS NORMAL AND DID NOT EXHIBIT SIGNS OF A USUAL ANEMIC SAMPLE. CUSTOMER DILUTED EACH SPECIMEN AND THE DILUTION OF 1 IN 2 GAVE RESULTS CLOSER TO THE FILM FOR RBC AND HGB FOR EACH AND IS CONSIDERED CORRECT. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. PATIENT RESULTS ARE ATTACHED. NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER AUTOMATED DIFFERENTIAL CELL COUNTER. GKZ BECKMAN COULTER INC. HMX AL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1