BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 INSTRUMENT

    MDR report key: 2133086 · Received June 18, 2011

    Report

    Report Number
    1061932-2011-00709
    Event Type
    Malfunction
    Date Received
    June 18, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS PROCESSED IN THE AUTOMATIC MODE AND THE ERRONEOUS PLT RESULT OCCURRED ON THE SPECIFIC SAMPLE. THE SPECIMEN WAS COLLECTED IN BD EDTA TUBE AND WAS 2.5 HRS OLD WHEN PROCESSED. CONTROLS WERE RUN PRIOR TO AND AFTER THE EVENT, AND WERE WITHIN QC SPECIFICATIONS. CONTROLS ARE PROCESSED TWICE DAILY. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND INSPECTED TUBING APERTURES AND APERTURE MODULES FOR ANY DEFECTS OR OBSTRUCTIONS. THE FSE ALSO RAN LATEX CALIBRATION OF THE APERTURES AND ADJUSTED APERTURE VOLTAGES TO IMPROVE. INSTRUMENT OPERATION WAS VERIFIED PER ESTABLISHED PROCEDURES. PER PRODUCT LABELING. THERE MAY BE SITUATIONS WHERE THE PRESENCE OF A RARE EVENT CELL MAY FAIL TO TRIGGER A SUSPECT MESSAGE. SYSTEM SENSITIVITY INCREASES WHEN APPROPRIATELY SET SUSPECT MESSAGES ARE USED IN COMBINATION WITH LABORATORY-DEFINED DEFINITIVE MESSAGES, ACTION VALUE FLAGS, AND CRITICAL VALUE FLAGS. IN ADDITION, COMPLETE REVIEW OF THE PERIPHERAL SMEAR, REGARDLESS OF THE NATURE OF THE FLAG, CODE, OR MESSAGE, WILL MINIMIZE FALSE NEGATIVES. KNOWN INTERFERENCES FOR PLT: VERY SMALL RED BLOOD CELLS NEAR THE UPPER THRESHOLD, CELL FRAGMENTS, CLUMPED PLATELETS AS WITH OXALATE OR HEPARIN, PLATELET FRAGMENTS, OR CELLULAR DEBRIS NEAR THE LOWER PLATELET THRESHOLD. GIANT PLATELETS, PLATELET CLUMPS, WHITE CELL FRAGMENTS, ELECTRONIC NOISE, VERY SMALL RED CELLS, RED CELL FRAGMENTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT AN ERRONEOUS LOW PLATELET (PLT) RESULT, WITH NO PLT CLUMP FLAG, WAS OBTAINED ON A SINGLE PATIENT SAMPLE RUN ON THE COULTER LH 500 INSTRUMENT. PER THE CUSTOMER, PLATELET CLUMPING WAS OBSERVED BY MANUAL SMEAR REVIEW. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. THE PATIENT WAS SENT TO THE EMERGENCY ROOM WHERE A NEW SPECIMEN WAS DRAWN. THE RESULT OBTAINED WAS WITHIN NORMAL RANGE, WHICH THE CUSTOMER CONSIDERS CORRECT. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN. THERE WERE NO REPORTS OF DEATH OR INJURY. CUSTOMER IS NOT AWARE OF ANY AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 500 INSTRUMENT AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. LH 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1