BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC-T DIFF 2 ANALYZER

    MDR report key: 2151663 · Received June 24, 2011

    Report

    Report Number
    1061932-2011-00740
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    February 26, 2008
    Report Date
    February 28, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL SAMPLE WAS FRESHLY DRAWN IN A VACUTAINER TUBE AND RAN IN CLOSED VIAL WHOLE BLOOD MODE. THE INSTRUMENT WAS OPERATIONAL AND WITHIN QUALITY CONTROL (QC) SPECIFICATIONS. QC WAS RUN ONCE A DAY AND WAS RUN BEFORE, BUT NOT AFTER THIS INCIDENT. QC RESULTS WERE WITHIN RANGE. FOLLOWING THIS INCIDENT THE CUSTOMER PERFORMED A CORRELATION STUDY USING TWO PT SAMPLES TO VALIDATE THE INSTRUMENT. ON (B)(4), 2008, THE FIELD SERVICE ENGINEER EVALUATED THE ANALYZER AND INSPECTED FLUIDICS, VERIFIED MIXING BUBBLES AND PERFORMED REPRODUCIBILITY, CARRY-OVER, START-UP AND QC RECOVERY. ALL PARAMETERS WERE WITHIN ACCEPTABLE LIMITS. ROOT CAUSE IS UNK, HOWEVER THE INITIAL SAMPLE WAS ADEQUATELY FLAGGED WITH INSTRUMENT GENERATED FLAGS TO ALERT THE CUSTOMER 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS TEST RESULTS FOR COMPLETE BLOOD COUNT (CBC) WHEN USING A COULTER AC-T DIFF 2 ANALYZER. THERE WERE INSTRUMENT GENERATED FLAGS FOR ALL TEST PARAMETERS. THE ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. 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 AC-T DIFF 2 ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK