BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2210114 · Received August 5, 2011

    Report

    Report Number
    1061932-2011-01084
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    March 9, 2010
    Report Date
    March 9, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS WERE RUN BEFORE THE AFTER THE INCIDENT AND RECOVERED WITHIN ASSAY LIMITS. ON (B)(6) 2010, THE FIELD SERVICE ENGINEER EVALUATED THE ANALYZER AND DETERMINED THAT THE RETICULOCYTE MIXING MOTOR WAS SLUGGISH. REPLACED THE MIXING MOTOR ASSEMBLY, THE STAIN PUMP AND VALVE VL129. ALSO REPLACED THE TUBING THROUGH VALVE VL94. VERIFIED INSTRUMENT PERFORMANCE TO SPECS. RAW DATA ANALYSIS WAS PERFORMED AND DETERMINED THAT THE ALGORITHM PERFORMED AS DESIGNED. ROOT CAUSE WAS DETERMINED TO BE ASSOCIATED WITH THE HARDWARE THAT WAS REPLACED DURING INSTRUMENT SERVICING FOR THIS PROBLEM. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS HIGH RETICULOCYTE TEST RESULTS WERE OBTAINED FOR ONE PT WHEN USING THE COULTER LH 780 HEMATOLOGY ANALYZER. THERE WERE NO INSTRUMENT GENERATED FLAGS WITH THE TEST RESULTS. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS WHEN COMPARED TO THE RESULTS OBTAINED WITH ANOTHER COULTER LH 780 HEMATOLOGY ANALYZER AND A MANUAL RETICULOCYTE COUNT. ERRONEOUS TEST RESULTS WERE NOT REPORTED OUT OF THE LAB. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT 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