BEUDAMED
    FDA Adverse Event Summary report: N

    COULTER® LH 780

    MDR report key: 2120919 · Received June 12, 2011

    Report

    Report Number
    1061932-2011-00626
    Date Received
    June 12, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 10, 2011
    Manufacturer
    BECKMAN COULTER INC
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 CF EVENT AND RECOVERED WITHIN ASSAY LIMITS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMERS CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO RECOVERING HIGH MCV RESULTS ON TWO PATIENTS' SAMPLES AND WERE ALERTED WHEN THEY WERE FAILING THEIR XM BATCH TESTING.THE RESULTS WERE REPORTED OUT OF THE LABORATORY. TWO PATIENT SAMPLES WERE RUN ON THE LH780 INSTRUMENT LH2 AND RERUN ON AN ALTERNATE INSTRUMENT (LH780 LH1). PATIENT RESULTS ARE PROVIDED. NO AFFECT OR CHANGE TO PATIENT TREAT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 780 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER INC LH 780 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1