BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER¿ COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2232132 · Received September 2, 2011

    Report

    Report Number
    1061932-2011-01368
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS THE PRIMARY SAMPLE ACQUIRED BY VENIPUNCTURE INTO A PLASTIC BD EDTA TUBE, MIXED BY INVERSION AND RUN WITHIN 15-20 MINUTES OF DRAW. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). CUSTOMER PERFORMS DAILY STARTUP/SHUTDOWN AND RUNS 5C CONTROLS ONCE A DAY. CONTROLS RUN BEFORE AND AFTER THE INCIDENT RECOVERED WITHIN RANGE. CUSTOMER IS FOLLOWING MAINTENANCE PROCEDURES AND MAINTENANCE IS PERFORMED IN A TIMELY MANNER. CBC LYSE WAS CHANGED (B)(6) 2011. THE CUSTOMER STATED THEY CHANGE DILUENT APPROXIMATELY EVERY OTHER DAY. IT WAS MOST RECENTLY CHANGED (B)(6) 2011 AND AGAIN ON (B)(6). PER RAW DATA ANALYSIS, THE RUNS PROVIDED WITH HIGH UNCORRECTED WHITE BLOOD COUNT (UWBC) AND LOW WBC ALL SHOW A TYPICAL HISTOGRAM PATTERN OF SEVERE INTERFERENCE. THE EXACT INTERFERENCE IS NOT KNOWN BUT THESE PATTERNS HAVE BEEN OBSERVED AND MAY BE DUE TO LIPIDS OR PROTEINS IN THE BLOOD. IN THESE CASES, THE INTERFERENCE CAUSES AN ELEVATED UWBC. WHEN THIS OCCURS, THE WBC COUNT IS CORRECTED FOR THE INTERFERENCE. AS IS THE CASE FOR THE PROVIDED SPECIMEN RUNS, WHEN THE INTERFERENCE IS TOO SEVERE, THE CORRECTED WBC IS FLAGGED FOR REVIEW WITH AN R FLAG. SIMILAR OBSERVATIONS CAN BE MADE FOR THE PLT RESULTS. NO SERVICE WAS SENT AS THIS WAS NOT OCCURRING WITH ANY OTHER PATIENTS, AND ALL QC RESULTS WERE WITHIN ACCEPTABLE LIMITS. TH ROOT CAUSE PER RAW DATA ANALYSIS IS ATTRIBUTED TO SEVERE SAMPLE SPECIFIC INTERFERENCE, ALTHOUGH THE EXACT INTERFERENCE IS NOT KNOWN. THE RESULTS DISPLAYED INSTRUMENT GENERATED FLAGS TO ALERT THE USER TO FURTHER REVIEW THE RESULTS. PER BEC PRODUCT LABELING: THE LH 700 SERIES APPLIES INSTRUMENT-GENERATED AND/OR LABORATORY-DEFINED FLAGS, CODES, AND/OR MESSAGES TO EACH SET OF PATIENT RESULTS. FLAGS, CODES, SUSPECT AND DEFINITIVE MESSAGES ARE USED TO ALERT YOU TO AN INSTRUMENT MALFUNCTION, SPECIMEN ABNORMALITY, ABNORMAL DATA PATTERN, OR ABNORMAL RESULTS. BECKMAN COULTER RECOMMENDS REVIEW, APPROPRIATE TO YOUR PATIENT POPULATION, OF ALL RESULTS DISPLAYING A FLAG, CODE OR OTHER MESSAGE. IMPORTANT BECKMAN COULTER, INC. DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN ALL SAMPLES. BECKMAN COULTER, INC. SUGGESTS USING ALL AVAILABLE FLAGGING OPTIONS TO OPTIMIZE THE SENSITIVITY OF INSTRUMENT RESULTS BASED ON YOUR PATIENT POPULATION. ALL FLAGGING OPTIONS INCLUDE REFERENCE RANGES (H/L), ACTION AND CRITICAL LIMITS, DEFINITIVE FLAGS, PARAMETER CODES, DELTA CHECKS, DECISION RULES AND SYSTEM ALARMS. BECKMAN COULTER, INC. RECOMMENDS AVOIDING THE USE OF SINGLE MESSAGES OR OUTPUTS TO SUMMARIZE SPECIMEN RESULTS OR PATIENT CONDITIONS. THERE MAY BE SITUATIONS WHERE THE PRESENCE OF A RARE EVENT MAY FAIL TO TRIGGER A SUSPECT MESSAGE. THIS REPORT IS RELATED TO THE FOLLOWING MDRS THAT ARE BEING REPORTED ON DIFFERENT DATES AND ON A DIFFERENT INSTRUMENT FOR THE SIMILAR EVENTS THAT OCCURRED AT THIS CUSTOMER SITE: 1061932-2011-01366, 1061932-2011-01367, 1061932-2011-01369.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE BECKMAN COULTER COULTER LH 750 HEMATOLOGY ANALYZER WAS GENERATING ERRATIC WHITE BLOOD COUNT (WBC), AND ERRONEOUSLY HIGH PLATELET (PLT) AND NUCLEATED RED BLOOD COUNT (NRBC) RESULTS WITH INSTRUMENT GENERATED FLAGS FOR TWO (2) SAMPLES DRAWN ON SEPARATE DAYS FROM A SPECIFIC PATIENT WHEN COMPARED TO RESULTS FROM A SECOND LH750 (ALTERNATE INSTRUMENT) AND MANUAL REVIEW OF SMEARS. THIS REPORT DOCUMENTS THE ERRONEOUS RESULTS OBTAINED ON (B)(6) 2011. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN THE ATTACHMENT SECTION OF THIS REPORT. THE CUSTOMER RERAN THE SAMPLE BECAUSE OF FLAGS THEN QUESTIONED THE RESULTS BECAUSE THE RERUN VALUES DID NOT CORRELATE WITH THOSE FROM THE INITIAL RUN. THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER¿ COULTER® LH 750 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR