BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2171271 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00799
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    March 27, 2008
    Report Date
    April 3, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. PRODUCT LABELING WAS EVALUATED. AS PER PRODUCT LABELING, THE COULTER LH 780 HEMATOLOGY ANALYZER IS INTENDED FOR ANALYSIS OF WHOLE BLOOD AND CEREBROSPINAL, SEROUS, AND SYNOVIAL FLUIDS AND NOT PLATELET CONCENTRATE. INSTRUMENT GENERATED MESSAGES ALERTS THE OPERATOR TO FURTHER REVIEW THE SAMPLE. ROOT CAUSE IS UNK, BUT MAY BE ATTRIBUTED TO THE TYPE OF SAMPLE USED. ADDITIONALLY, INSTRUMENT GENERATED MESSAGES ALERTS THE OPERATOR TO FURTHER REVIEW THE SAMPLE. 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 MDR REPRESENTS EVENT 1 OF 2 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 1061932-2011-00800.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS TEST RESULTS WERE OBTAINED FOR A PLATELET CONCENTRATE PRODUCT SAMPLE WHEN USING THE COULTER LH 780 HEMATOLOGY ANALYZER. ERRONEOUS TEST RESULTS WERE RELEASED FOR THE PLATELET CONCENTRATE PRODUCT SAMPLE. THE TEST RESULTS WERE QUESTIONED, PROMPTING THE LAB TO REVIEW THE TEST RESULTS. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 1 OF 2 EVENTS REPORTED BY THIS CUSTOMER. THIS IS THE FIRST OF TWO PLATELET CONCENTRATE PRODUCTS TESTED ON TWO SEPARATE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 780 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK