BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2171173 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00769
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    March 11, 2008
    Report Date
    March 11, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PT SAMPLE COLLECTED IN A 5CC VACUTAINER TUBE. SAMPLE WAS LESS THAN 2 HOURS OLD AND STORED AT ROOM TEMPERATURE. 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 REPLACED THE WBC DILUENT DISPENSER, FLUSHED THE DRAIN VENT LINE FROM THE RBC BATH, AND VERIFIED INSTRUMENT PERFORMANCE. RAW DATA ANALYSIS WAS CONDUCTED, SUGGESTED THE SAMPLES MAY NOT HAVE BEEN ADEQUATELY MIXED PRIOR TO ANALYSIS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2008 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS LOW TEST RESULTS FOR WHITE BLOOD CELL (WBC) AND PLATELETS (PLT) AND HIGH TEST RESULTS FOR RED BLOOD CELL (RBC) AND HEMOGLOBIN (HGB) ON ONE PT SAMPLE WHEN USING THE 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.

    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