BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2161126 · Received June 17, 2011

    Report

    Report Number
    1061932-2011-00634
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    September 24, 2008
    Report Date
    September 26, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALL SAMPLES WERE FRESH DRAWS. THE INSTRUMENT WAS PERFORMING WITHIN QUALITY CONTROL SPECIFICATIONS. CONTROLS WERE RUN EVERY SHIFT (THREE TIMES PER DAY). THE 5C CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT AND RECOVERED WITHIN SPECIFICATIONS. REVIEW OF LATRON CONTROLS SUBMITTED, SHOWED CONDUCTIVITY WAS HIGH OUT ON (B)(6) 2008. ON (B)(4) 2008, THE FIELD SERVICE ENGINEER (FSE) ADJUSTED THE VOLTAGE WHICH WAS FOUND TOO HIGH FOR VOLUME AND REPLACED THE FLOW CELL TO FIX THE PROBLEM WITH THE RETICULOCYTE BACKGROUNDS READING +++ AT START UP. ON (B)(4) 2008, FSE CLEANED AND ADJUSTED THE FLOW CELL AND LIGHT SCATTER SENSOR. RAW DATA FILES WERE NO LONGER AVAILABLE FOR ANALYSIS. ROOT CAUSE WAS ATTRIBUTED TO MISALIGNMENT/DIRT IN THE TRIPLE TRANSDUCER MODULE AREA. 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 3 OF 9 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 1061932-2011-00632, 00633, 00635, 00636, 00637, 00638, 00639, 00640.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS ELEVATED EOSINOPHIL% AND LOW NEUTROPHIL% FOR 22 PATIENTS TESTED BETWEEN THE DATES OF (B)(6) 2008. TESTING WAS PERFORMED USING A COULTER LH 750 HEMATOLOGY ANALYZER. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS WHEN COMPARED TO A SECOND ANALYZER WHICH WAS CONSIDERED CORRECT. ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. NOTIFICATION TO ALL NURSES AND PHYSICIANS INVOLVED WITH THE PATIENTS WITH INCORRECT TEST REPORTS WAS COMPLETED. THERE WERE NO REPORTS OF ADVERSE AFFECTS TO PATIENT TREATMENT. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 3 OF 9 EVENTS REPORTED BY THIS CUSTOMER FOR THE 22 PATIENTS INVOLVED. THIS MDR IS FOR (B)(6) 2008, EVENING WORK SHIFT. AN MDR WAS SUBMITTED FOR EACH WORK SHIFT OF EACH DAY.

    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