BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2210115 · Received August 5, 2011

    Report

    Report Number
    1061932-2011-01085
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    March 9, 2010
    Report Date
    March 9, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS PERFORMING WITHIN QC SPECS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). CONTROLS WERE RUN BEFORE THE INCIDENT AND RECOVERED WITHIN ASSAY RANGE. ON (B)(4) 2010, THE FIELD SERVICE ENGINEER CHECKED THE DIFFERENTIAL COUNT TIMES AND VERIFIED THE LASER STATUS. VERIFIED INSTRUMENT PERFORMANCE TO SPECS. RAW DATA ANALYSIS WAS PERFORMED. THE EOSINOPHILS APPEAR WITHIN THE TYPICAL NEUTROPHIL REGION. THE ALGORITHM CLASSIFIED THE EOSINOPHILS AS NEUTROPHILS AND SET THE VERIFY DIFF FLAG BECAUSE THERE ARE TWO SEPARATE NEUTROPHIL POPULATIONS AS A RESULT OF ERRONEOUS CLASSIFICATION. ROOT CAUSE WAS DETERMINED TO BE THE ALGORITHM COULD NOT CLASSIFY THE TWO POPULATIONS CORRECTLY. THE INSTRUMENT DID GENERATE VERIFY DIFF AND R MESSAGES THAT ALERT THE OPERATOR TO FURTHER REVIEW THE SPECIMEN. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS LOW DIFFERENTIAL TEST RESULTS WERE OBTAINED FOR ONE PT SAMPLE WHEN USING THE COULTER LH 500 HEMATOLOGY ANALYZER. ERRONEOUS TEST RESULTS WERE NOT REPORTED OUT OF THE LAB. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS WHEN THE TEST RESULTS WERE COMPARED TO TESTING OBTAINED ON A COULTER LH 750 HEMATOLOGY ANALYZER AND MANUAL DIFFERENTIAL. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR