BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2210153 · Received August 5, 2011

    Report

    Report Number
    1061932-2011-01079
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    March 4, 2010
    Report Date
    March 4, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS WITHIN QUALITY CONTROL SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). CONTROLS WERE RUN BEFORE AND AFTER THIS INCIDENT AND RECOVERED WITHIN ASSAY LIMITS. ON (B)(4) 2010, THE FIELD SERVICE ENGINEER (FSE) PERFORMED LYSE DILUENT TIMING AND REPLACED SAMPLES LINE TUBING TO THE FLOWCELL. VERIFIED PERFORMANCE TO SPECIFICATIONS. ON (B)(4) 2010, THE FSE RAN REPRODUCIBILITY AND ALL PARAMETERS WERE WITHIN SPECS. VERIFIED PERFORMANCE TO SPECS. RAW DATA ANALYSIS WAS UNABLE TO BE CONDUCTED BECAUSE THE RAW DATA FILES FOR THE ERRONEOUS HIGH BASOPHIL TEST RESULTS WERE NOT PROVIDED BY THE CUSTOMER. ROOT CAUSE WAS NOT DETERMINED. THERE WAS AN INSTRUMENT GENERATED FLAG (IMM. NE 1 DIFFERENTIAL FLAG) WHICH ALERTED 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. THIS MDR REPRESENTS EVENT 1 OF 2 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO MDR 1061932-2011-01080.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS HIGH BASOPHIL% TEST RESULTS WERE OBTAINED ON A DIFFERENTIAL WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THERE WAS AN INSTRUMENT GENERATED FLAG WITH THE DIFFERENTIAL RESULTS. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS WHEN COMPARED TO NORMAL BASOPHIL% TEST RESULTS OBTAINED WHEN THE SAMPLE WAS RETESTED ON A COULTER LH 780 HEMATOLOGY ANALYZER AND THE SAME COULTER LH 750 HEMATOLOGY ANALYZER. ERRONEOUS TEST RESULTS WERE NOT REPORTED OUT OF THE LAB. 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 REPORTED BY THIS CUSTOMER WITH TWO DIFFERENT PT SAMPLES AND TWO DIFFERENT ANALYZERS.

    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