BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2171172 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00715
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    February 15, 2008
    Report Date
    February 15, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT SAMPLE WAS COLLECTED IN A 4ML K2 EDTA TUBE. SAMPLE WAS 2 HOURS OLD AND STORED AT ROOM TEMPERATURE. NOTE: K2 EDTA = POTASSIUM ETHYLENEDIAMINETETRAACETIC ACID. THE ANALYZERS WERE WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). CONTROLS ARE RUN EVERY 24 HOURS OR WHEN REAGENTS ARE CHANGED. SAMPLES WERE NOT RUN BACK TO THE LAST ACCEPTABLE CONTROL RUN. CONTROLS WERE RUN BEFORE BUT NOT AFTER THIS EVENT AND WERE WITHIN ACCEPTABLE RANGES. ON (B)(4) 2008, THE FIELD SERVICE ENGINEER OBSERVED PARTIAL PLUGS IN TWO WBC APERTURES AND A COMPLETE PLUG IN THE THIRD APERTURE. THE CUSTOMER BLEACHED THE APERTURES (BEFORE FSE ARRIVED) AND THE FSE CLEARED THE PLUGS AND VERIFIED THE INSTRUMENT OPERATION. RAW DATA ANALYSIS SUPPORTED THE CONCLUSION OF THE FSE THAT THE APERTURES WERE CLOGGED. WHEN THE INSTRUMENT REPORTED A WBC COUNT OF 0.5, THE WBC BATH HAD TWO PARTIAL PLUGGED APERTURES, APERTURE #1 AND APERTURE #2. BOTH APERTURES' REPORTED VERY LOW WBC COUNTS AND THEIR HISTOGRAMS SHOWED SOME DEBRIS OR NOISE AT THE LOW END. APERTURE #3 REPORTED A WBC COUNT OF 8.04. THE REPORTED WBC VALUE OF 0.5 WAS THE AVERAGE OF APERTURE #1 AND APERTURE #2 SINCE THEY WERE THE CLOSE PAIR OF VALUES. ROOT CAUSE WAS THE CLOGGED APERTURES. 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 LOW WHITE BLOOD CELL (WBC) TEST RESULTS WERE OBTAINED WHEN USING A COULTER LH 750 HEMATOLOGY ANALYZER. THERE WERE NO INSTRUMENT GENERATED FLAGS FOR THESE TEST RESULTS. THE TEST RESULTS WERE DETERMINED TO THE ERRONEOUS BASED ON COMPARISON TO A MANUAL WBC ESTIMATE AND TEST RESULTS OBTAINED USING ANOTHER COULTER LH 750 HEMATOLOGY ANALYZER. THE ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LAB. A CORRECTED 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