BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT 5DIFF HEMATOLOGY ANALYZER

    MDR report key: 2210133 · Received August 5, 2011

    Report

    Report Number
    1061932-2011-01060
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    February 17, 2010
    Report Date
    February 17, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K992511
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC CALL CENTER TO REQUEST SERVICE FOR THE ERRONEOUS HIGH BASOPHIL% TEST RESULTS. THE CUSTOMER DID NOT PROVIDE PT DATA OR PRINTOUTS. IT IS UNK THE DATES OF TESTING, NUMBER OF PT SAMPLES INVOLVED, OR IF THERE WERE INSTRUMENT GENERATED FLAGS OR ERROR MESSAGES ASSOCIATED WITH THE TEST RESULTS. THE INSTRUMENT WAS PERFORMING WITH QC SPECS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). CONTROLS WERE RUN BEFORE AND AFTER THIS INCIDENT AND RECOVERED WITHIN LIMITS. ON (B)(6) 2010, THE FIELD SERVICE ENGINEER (FSE) REPLACED VALVE 14 AND PERFORMED REPRODUCIBILITY. VERIFIED INSTRUMENT PERFORMANCE TO SPECS. ROOT CAUSE IS UNK BUT MAYBE RELATED TO THE HARDWARE REPLACED BY FSE DURING INSTRUMENT SERVICING. 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 PASOPHIL% TEST RESULTS WERE OBTAINED WHEN USING THE COULTER ACT 5DIFF HEMATOLOGY ANALYZER. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS WHEN COMPARED TO TEST RESULTS OBTAINED FROM A REFERENCE LAB. TEST RESULTS WERE NOT PROVIDED. ERRONEOUS TEST RESULTS WERE 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 ACT 5DIFF HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK