BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMTOLOGY ANALYZER

    MDR report key: 2210151 · Received August 5, 2011

    Report

    Report Number
    1061932-2011-01078
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    February 25, 2010
    Report Date
    March 3, 2010
    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

    THE INSTRUMENT WAS WITHIN QUALITY CONTROL SPECS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). CONTROLS WERE RUN EVERY 8 HOURS. CONTROLS WERE RUN BEFORE AND AFTER THIS EVENT AND WERE WITHIN ACCEPTABLE RANGES. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. RAW DATA ANALYSIS WAS CONDUCTED. THERE WAS NO SUPPORTING DATA FOR THE PRESENCE OF PLATELET CLUMPS. ROOT CAUSE FOR ERRONEOUS LOW PLATELETS IS THE PRESENCE OF PLATELET CLUMPS, A KNOWN INTERFERING SUBSTANCE IDENTIFIED IN PRODUCT LABELING. 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. THIS ISSUE WAS REPORTED IN 2010 AS MDR 1061932-2010-00026. DURING THE RETROSPECTIVE REVIEW, IT WAS DETERMINED THAT ADD'L MDRS WERE REQUIRED TO BE FILED. THIS MDR REPRESENTS EVENT 4 OF 4 REPORTED. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: 1061932-2011-01076, 1061932-2011-01077.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS LOW PLATELET COUNTS WERE OBTAINED FOR ONE PT WHEN USING A COULTER LH 750 HEMATOLOGY ANALYZER. THE ERRONEOUS LOW PLATELET COUNT WAS REPORTED. SUBSEQUENT TESTING DETERMINED THAT THE PLATELET COUNT WAS ERRONEOUSLY LOW, AND PLATELET CLUMPS WERE PRESENT ON BLOOD SMEAR ANALYSIS. THIS EVENT REPRESENTS EVENT 4 OF 4 EVENTS REPORTED BY THIS CUSTOMER FOR TESTING PERFORMED ON THIS PT WITH THREE DIFFERENT ANALYZERS OVER THREE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 HEMTOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK