BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2152298 · Received June 24, 2011

    Report

    Report Number
    1061932-2011-00724
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    January 11, 2008
    Report Date
    February 6, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    APPROX 15 MINS ELAPSED BETWEEN THE TIME THE INSTRUMENT STOPPED (DUE TO WASTE ALARM FULL) AND THE TIME THE INSTRUMENT RESUMED OPERATIONS. THE SAMPLES REMAINED IN THE SYSTEM IN A PRONE IDLE POSITION DURING THIS TIME. THE SAMPLE TUBE (THAT GENERATED THE ERRONEOUS RESULTS) WAS THE FIRST TUBE ANALYZED AFTER THE INSTRUMENT RESUMED OPERATIONS. THE BECKMAN COULTER REP ADVISED THE LAB PERSONNEL TO RESUME SYSTEM OPERATION AFTER ANY REAGENT ALARM BY USING THE "PREMIX" INSTEAD OF "START" IN ORDER TO MIX SAMPLE PRIOR TO ANALYSIS. SERVICE WAS NOT REQUIRED FOR THE ANALYZER. BASED ON THE AVAILABLE INFO, THE ROOT CAUSE OF THE DISCREPANCY IN RESULTS OBSERVED IS UNK. HOWEVER, IT IS POSSIBLY RELATED TO POOR PRE-ANALYTICAL SAMPLE MIXING. 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS TEST RESULTS WHEN USING THE COULTER LH 780 HEMATOLOGY ANALYZER. ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. THE TEST RESULTS WERE QUESTIONED BY THE PHYSICIAN. THE PT WAS REDRAWN. CORRECT RESULTS WERE OBTAINED AND RELEASED. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO EFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.

    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