BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2183615 · Received July 8, 2011

    Report

    Report Number
    1061932-2011-00819
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    April 24, 2008
    Report Date
    April 24, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLE WAS COLLECTED VIA HEEL STICK IN MICROTAINER TUBE. THE FIRST SAMPLE WAS HEMOLYZED AND WAS CHECK FOR CLOTS. THE INSTRUMENT WAS WITHIN QUALITY CONTROL SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). ON (B)(4) 2008, THE FIELD SERVICE ENGINEER EVALUATED THE ANALYZER AND VERIFIED INSTRUMENT PERFORMANCE. RAW DATA ANALYSIS WAS PERFORMED. ROOT CAUSE BASED ON THE RAW DATA ANALYSIS IS THAT ON BOTH SAMPLES, THE WBC HISTOGRAMS SHOWED A TYPICAL PATTERN OF SEVERE INTERFERENCE. THE WBC CORRECTION WAS PERFORMED AND A R (REVIEW) FLAG WAS SET TO INDICATE LOW CONFIDENCE. THE ALGORITHM PERFORMED AS DESIGNED AND THE INSTRUMENT DID GENERATE AN ADEQUATE FLAG TO ALERT THE CUSTOMER TO FURTHER REVIEW THE SAMPLE. PRODUCT LABELING INDICATES THAT INSTRUMENT GENERATED MESSAGES ALERT 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ERRONEOUS LOW WHITE BLOOD CELL (WBC) AND PLATELET COUNTS WERE OBTAINED WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE TEST RESULTS WERE ACCOMPANIED BY INSTRUMENT GENERATED R (REVIEW), CELLULAR INTERFERENCE, AND GIANT PLATELET FLAGS. THE ERRONEOUS LOW WBC COUNT WAS REPORTED OUT OF THE LABORATORY WITH A DISCLAIMER. A MANUAL WBC ESTIMATE WAS PERFORMED AND WAS HIGHER THAN THE REPORTED TEST RESULTS. THERE WAS INSUFFICIENT SAMPLE TO REPEAT THE TEST. THE PATIENT WAS REDRAWN AND TESTING PERFORMED ON THE COULTER LH 750 HEMATOLOGY ANALYZER AND COULTER LH 500 HEMATOLOGY ANALYZER . THE RESULTS WERE SIMILAR TO THE MANUAL WBC ESTIMATE OBTAINED ON THE FIRST SAMPLE. A CORRECTED REPORT WAS ISSUED. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    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