BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2230097 · Received August 31, 2011

    Report

    Report Number
    1061932-2011-01331
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIMEN COLLECTION AND STORAGE INFORMATION WERE NOT PROVIDED. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY AND PRECISION). PREVIOUSLY RUN PATIENT SAMPLES WERE RERUN TO CONFIRM BACK TO THE LAST ACCEPTABLE CONTROL RUN. CONTROLS WERE RUN BEFORE THE INCIDENT AND RECOVERED WITHIN ASSAY RANGES. RAW DATA WAS REQUESTED BUT IS NO LONGER AVAILABLE. NO SERVICE WAS PERFORMED ON THIS INSTRUMENT. THE ROOT CAUSE FOR THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT COULTER LH 500 HEMATOLOGY ANALYZER GENERATED ERRONEOUS DIFFERENTIAL RESULTS WITH BASOPHIL RESULT OF 10.1%. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. TESTING ON AN ALTERNATE INSTRUMENT RECOVERED BASOPHIL RESULTS OF 65.2% AND 0.8% (THIS EVENT IS REPORTED IN A SEPARATE REPORT #1061932-2011-01330). A MANUAL DIFFERENTIAL WAS PERFORMED WITH 9 BASOPHILS SEEN ON THE SMEAR. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. LH500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR