BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2210132 · Received August 5, 2011

    Report

    Report Number
    1061932-2011-01103
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    March 10, 2010
    Report Date
    March 11, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS WITHIN QC SPECS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). RAW DATA WAS REQUESTED, BUT NOT PROVIDED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE ROOT CAUSE IS UNK, BUT MAYBE RELATED TO THE SAMPLE. THE LH500 INSTRUMENT DID GENERATE FLAGS. THESE INSTRUMENTS FLAGS ALERT THE OPERATOR TO FURTHER REVIEW THE SPECIMEN. PRODUCT LABELING INDICATES THE FOLLOWING FOR INTERFERING SUBSTANCES: WBC: NRBCS, GIANT PLATELETS, PLATELET CLUMPS, MATERIAL PARASITES, PRECIPITATED ELEVATED PROTEINS, CRYOGLOBULIN, MICROLYMPHOBLASTS, VERY SMALL LYMPHOCYTES, FRAGMENTED WHITE CELLS, AGGLUTINATED WHITE CELLS, LYSE RESISTANT RED CELLS, UNLYSED PARTICLES > 35 FL IN SIZE. NRBC: KNOWN INTERFERENCES RELATED TO LYSE RESISTANT RED CELLS, PLATELET CLUMPS, GIANT PLATELETS, MALARIAL PARASITES, VERY SMALL OR MULTI-POPULATION LYMPHOCYTES, PRECIPITATED ELEVATED PROTEINS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 2 OF 2 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO MDR 1061932-2011-01102.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS HIGH WHITE BLOOD CELL (WBC) AND LOW NUCLEATED RED BLOOD CELL (NRBC) COUNTS WERE OBTAINED FOR ONE PT SAMPLE WHEN USING A COULTER LH 500 HEMATOLOGY ANALYZER. THERE WERE INSTRUMENT GENERATED MESSAGES WITH THE TEST RESULTS. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS WHEN COMPARED TO A MANUAL BLOOD SMEAR DIFFERENTIAL. 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. THIS EVENT REPRESENTS EVENT 2 OF 2 EVENTS REPORTED BY THIS CUSTOMER FOR TWO DIFFERENT ANALYZERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 500 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 HR