BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2183619 · Received July 8, 2011

    Report

    Report Number
    1061932-2011-00815
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    April 8, 2008
    Report Date
    April 10, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS WITHIN QUALITY CONTROL SPECS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. ON (B)(4) 2008, THE FIELD SERVICE ENGINEER EVALUATED THE ANALYZER AND VERIFIED INSTRUMENT PERFORMANCE. RAW DATA ANALYSIS WAS PERFORMED AND INDICATED MERGED NEUTROPHIL/EOSINOPHIL POPULATIONS. IMM NE 1 AND IMM NE 2 WERE GENERATED FOR SUBSEQUENT RETESTS WHEN THE ALGORITHM IDENTIFIED THE MERGED POPULATIONS AS ABNORMAL. ROOT CAUSE IS UNK. 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. THIS MDR REPRESENTS EVENT 1 OF 2 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 1061932-2011-00816.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS LOW DIFFERENTIAL RESULTS FOR EOSINOPHIL% OF 0.0 WERE OBTAINED WHEN USING A COULTER LH 750 HEMATOLOGY ANALYZER. TEST RESULTS WERE DETERMINED TO BE ERRONEOUS BASED ON RETEST OF THE COULTER LH 750 HEMATOLOGY ANALYZER AND A COULTER GEN-S SYSTEM, IN ADDITION TO A MANUAL BLOOD SMEAR DIFFERENTIAL. ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LAB. A CORRECTED REPORT WAS ISSUED. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 1 OF 2 EVENTS REPORTED BY THIS CUSTOMER. THIS EVENT IS FOR THE FIRST OF TWO SAMPLES FROM THIS PT TESTED OVER 2 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK