BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2151661 · Received June 24, 2011

    Report

    Report Number
    1061932-2011-00739
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    February 21, 2008
    Report Date
    February 21, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYZER WAS RUNNING WITHIN QUALITY CONTROL SPECIFICATIONS. CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT. H3: THE FIELD SERVICE ENGINEER (FSE) REALIGNED OPTICS AND REPLACED THE THREE ELEMENT SCATTER SENSOR TO CORRECT THE PROBLEM ON (B)(4) 2008. ON (B)(4) 2008, THE FSE CONFIRMED WITH THE LABORATORY THAT PROBLEM WAS RESOLVED. ROOT CAUSE FOR THE ERRONEOUS DIFFERENTIALS RELATED TO THE OPTICS MISALIGNMENT AND/OR THE SCATTER SENSOR. 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 4 OF 4 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 1061932-2011-00736, 00737, 00738.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS DIFFERENTIAL RESULTS WHEN USING A COULTER LH 750 HEMATOLOGY ANALYZER. THIS OCCURRED INTERMITTENTLY OVER 2 DAYS. THE INITIAL TEST RESULTS WERE QUESTIONED BY THE OPERATOR WHEN HIGH EOSINOPHIL% WAS OBTAINED. WHEN THE SAMPLES WERE RERUN, CORRECT TEST RESULTS WERE OBTAINED. THE INITIAL RESULTS WERE DETERMINED TO BE ERRONEOUS BASED ON THE RERUN AND/OR MANUAL DIFFERENTIALS. ERRONEOUS TEST RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 4 OF 4 EVENTS REPORTED BY THIS CUSTOMER. THIS EVENT IS FOR TWO SAMPLES TESTED ON THE DAY SHIFT 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