BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2172150 · Received June 15, 2011

    Report

    Report Number
    1061932-2011-00589
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    October 14, 2008
    Report Date
    October 28, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE OPTIMIZED THE INSTRUMENT AND PERFORMED INSTRUMENT VERIFICATION ON (B)(4) 2008. ROOT CAUSE IS UNK FOR THE DISCREPANCY BETWEEN THE INSTRUMENT NRBC VALUE AND THE MANUAL DIFFERENTIAL FOR THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 3 OF 3 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 1061932-2011-00587, 1061932-2011-00588.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS NUCLEATED RED BLOOD CELL (NRBC) TEST RESULTS OF 2.0 WERE OBTAINED WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE ERRONEOUS TEST RESULTS OCCURRED WITH A SPECIFIC PT SAMPLE. THERE WAS AN INSTRUMENT GENERATED FLAG OF "R" SPECIFIC FOR NRBC. (AN R FLAG IS A FLAG TO ALERT THE OPERATOR TO PERFORM A REVIEW PER LABORATORY PROCEDURE). THERE WAS AN INSTRUMENT GENERATED DIFFERENTIAL FLAG AND A MANUAL DIFFERENTIAL WAS PERFORMED. NRBC TEST RESULT OF 0 (ZERO) WAS OBTAINED. IT IS UNK IF ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY FOR THIS EVENT. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 3 OF 3 EVENTS REPORTED BY THIS CUSTOMER FOR THE SAME PT TESTED ON THREE SEPARATE OCCASIONS. THIS REPORT IS FOR THE TESTING PERFORMED ON (B)(6) 2008.

    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