BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3171377 · Received June 14, 2013

    Report

    Report Number
    1061932-2013-01165
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. THE CUSTOMER-SUPPLIED RAW DATA AND HISTOGRAMS WERE REVIEWED. THERE WAS NO INDICATION OF ANY SYSTEM FAILURE. THE CAUSE FOR THE DIFFERENCE BETWEEN THE MANUAL ESTIMATE AND THE INSTRUMENT REPORTED RESULTS CANNOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A DEFINITIVE CAUSE OF THE INCIDENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LOW PLATELET RESULTS WITH GENERATED R AND GIANT PLATELET FLAGS, FOR ONE ANEMIC PATIENT, INVOLVING THE COULTER® LH 500 HEMATOLOGY ANALYZER. THE CUSTOMER STATED THE PATIENT¿S SAMPLE WAS ANALYZED THREE TIMES, OBTAINING PLATELET RESULTS BETWEEN 296-340 (X10^3 CELLS/UL). THE MANUAL SMEAR INDICATED A PLATELET COUNT OF 516 (X10^3 CELLS/UL). THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER INDICATED QUALITY CONTROL (QC) WAS WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ALL RESULTS WERE ANALYZED FROM DIFFERENT SAMPLE COLLECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270645 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR