BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2183645 · Received July 8, 2011

    Report

    Report Number
    1061932-2011-00818
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    April 20, 2008
    Report Date
    April 23, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS PERFORMING WITHIN QUALITY CONTROL SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). PREVIOUSLY RUN PT SAMPLE WERE NOT RERUN TO CONFIRM BACK TO THE LAST ACCEPTABLE RUN. CONTROLS WERE RUN EVERY 24 HOURS AND WERE WITHIN ACCEPTABLE LIMITS BEFORE AND AFTER THIS INCIDENT. CUSTOMER INDICATED THAT THIS EVENT WAS DUE TO INADEQUATELY MIXED SAMPLE AND DECLINED SERVICE. AS OF (B)(6) 2008, NO OTHER INCIDENTS HAVE OCCURRED. DATA PATTERN (LOW WBC/PLT AND HIGH RBC/HGB) OF THE INITIAL RUN IS INDICATIVE OF AN INADEQUATELY MIXED SAMPLE. PROD LABELING STATES: "MISLEADING RESULTS COULD OCCUR IF YOU FAIL TO LEAVE SPACE AT THE TOP OF THE TUBE BETWEEN THE SAMPLE AND THE STOPPER. ENSURE YOU LEAVE SPACE AT THE TOP OF THE TUBE BETWEEN THE SAMPLE AND THE STOPPER TO FACILITATE MIXING. ALSO, ENSURE THAT THE SAMPLE IS PROPERLY MIXED BEFORE ANALYSIS." ROOT CAUSE UNK, BUT MAY BE ATTRIBUTED TO PRE-ANALYTICAL SAMPLE MIXING. 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS COMPLETE BLOOD COUNT (CBC) TEST RESULTS WERE OBTAINED WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THERE WERE NO INSTRUMENT GENERATED FLAGS WITH THE TEST RESULTS. ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. THE TEST RESULTS WERE FLAGGED BY THE LABORATORY INFO SYSTEM (LIS) WITH A DELTA CHECK, I.E THE TEST RESULTS DIFFERED FROM THE PT'S HISTORICAL TEST RESULTS. THE SAMPLE WAS TESTED AGAIN ON (B)(6) 2008, AND A CORRECTED TEST REPORT WAS ISSUED. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT 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