BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 2267009 · Received September 16, 2011

    Report

    Report Number
    1061932-2011-01450
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    June 28, 2010
    Report Date
    June 29, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS ARE RUN ONCE PER DAY AND WERE RUN BEFORE THIS EVENT AND WERE WITHIN ACCEPTABLE RANGES. THE INSTRUMENT WAS WITHIN QUALITY CONTROL SPECS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). SERVICE WAS NOT DISPATCHED. RAW DATA ANALYSIS REVEALED THAT THE SAMPLE WAS AN EXTREMELY RARE SAMPLE WITH THE RBC HISTOGRAM MAIN PEAK IN THE LOW END. THE ALGORITHM DETECTED HIGH END INTERFERENCE FOR PLT AND LOW END INTERFERENCE FOR RBC, BUT UNABLE TO MAKE A GOOD DECISION ABOUT THE BOUNDARY BETWEEN PLT AND RBC. REVIEW FLAGS WERE GENERATED FOR BOTH PLT AND RBC RELATED PARAMETERS. THE ALGORITHM PERFORMED AS DESIGNED. THE ROOT CAUSE FOR ERRONEOUS RBC, HCT, RDW AND PLATELET RESULTS IS UNK; HOWEVER THE INSTRUMENT DID GENERATE R FLAGS THAT ALERT THE OPERATOR TO FURTHER REVIEW THE SPECIMEN. PER PRODUCT HISTORY: RED CELL FRAGMENTS ARE A KNOWN INTERFERING SUBSTANCE FOR RBC, PLATELET AND HOT PARAMETERS. 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 LOW RED BLOOD CELL (RBC) COUNT, HEMATOCRIT (HCT), AND RED CELL DISTRIBUTION WIDTH (RDW) AND ERRONEOUS HIGH PLATELET (PLT) COUNTS WERE OBTAINED WHEN USING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THERE WERE INSTRUMENT GENERATED "R" (REVIEW) FLAGS WITH THE RESULTS. 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 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR