BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2139298 · Received June 17, 2011

    Report

    Report Number
    1061932-2011-00605
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    November 17, 2008
    Report Date
    November 17, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042723
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN A 5 CC VACUTAINER AND STORED AT ROOM TEMP. THE INSTRUMENT WAS PERFORMING WITHIN QUALITY CONTROL (QC) SPECIFICATIONS. CONTROLS WERE RUN BEFORE AND AFTER THE EVENT. CONTROL RESULTS RECOVERED WITHIN RANGE. ON (B)(6) 2008, FIELD SVC ENGINEER (FSE) REVIEWED LACK OF EOSINOPHIL% ON PT SAMPLE RESULTS. FSE PERFORMED PREVENTIVE MAINTENANCE. BASED ON THE AVAILABLE INFO, ROOT CAUSE FOR ERRONEOUS DIFFERENTIAL RESULTS IS UNK. HOWEVER, THE INSTRUMENT ADEQUATELY FLAGGED THE RESULTS PROMPTING THE OPERATOR TO FURTHER REVIEW THE SAMPLE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 1 OF 2 REPORTED FOR THIS PT SAMPLE. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 1061932-2011-00604.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS EOSINOPHIL% OF 0.5% AND ERRONEOUS DIFFERENTIAL RESULTS WHEN USING A COULTER LH 500 HEMATOLOGY ANALYZER. INSTRUMENT GENERATED FLAGS WERE PRESENT WITH THE DIFFERENTIAL TEST RESULTS. THE DIFFERENTIAL RESULTS WERE DETERMINED TO BE ERRONEOUS BASED ON THE MANUAL DIFFERENTIAL. THE EOSINOPHIL% WAS 44% ON MANUAL DIFFERENTIAL. ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. A CORRECTED REPORT WAS ISSUED. AFFECT TO PT TREATMENT IS UNK. NO REPORTS OF DEATH OR SERIOUS INJURY AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 1 OF 2 EVENTS REPORTED FOR THIS PT SAMPLE.

    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 46 YR Other