BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2180410 · Received July 27, 2011

    Report

    Report Number
    1061932-2011-01004
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 26, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: ERRONEOUS DATA GENERATED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT UNEXPECTEDLY HIGH MEAN CELL VOLUME (MCV) PATIENT AND QUALITY CONTROL RESULTS ON THEIR COULTER LH 750 HEMATOLOGY ANALYZER. THE PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT PROVIDE SPECIFIC PATIENT DATA OR THE NUMBER OF PATIENT RESULTS IMPACTED BY THIS EVENT. THERE WAS NO IMPACT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPORTED THAT THE CALIBRATION FACTORS FOR THE ANALYZER WERE CHANGED FOLLOWING SERVICE BY BEC (FOR ANOTHER ISSUE) AND THAT THE MCV RESULTS WERE RECOVERING HIGHER FOR BOTH QUALITY CONTROLS AND PATIENT SAMPLES (PATIENT SAMPLE RESULTS WERE NOT MATCHING PATIENT HISTORY). BEC SENT THE CUSTOMER A NEW CALIBRATION KIT AND SET OF CONTROLS. USING THE NEW CALIBRATION KIT AND CONTROLS, THE CUSTOMER SUCCESSFULLY CALIBRATED THE ANALYZER. THE CUSTOMER REPORTED NO FURTHER MCV RECOVERY ISSUES FOLLOWING THE RECALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. LH750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1