BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2466219 · Received February 23, 2012

    Report

    Report Number
    1061932-2012-00582
    Event Type
    Malfunction
    Date Received
    February 23, 2012
    Date of Event
    January 24, 2012
    Report Date
    January 31, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYZER WAS NOT EVALUATED BY BECKMAN COULTER FIELD SERVICE PERSONNEL AT THE TIME OF THE EVENT. RAW DATA FILES WERE REQUESTED FOR EVALUATION, BUT WERE NOT PROVIDED BY THE CUSTOMER. THE CAUSE OF THE ERRONEOUS RESULTS IS UNKNOWN BASED ON THE INFORMATION PROVIDED. PRODUCT LABELING WAS EVALUATED. UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM INSTRUCTIONS FOR USE, PN629743: GIANT PLATELETS, PLATELET CLUMPS, WHITE CELL FRAGMENTS, ELECTRONIC NOISE, VERY SMALL RED CELLS, RED CELL FRAGMENTS ARE LISTED AS LIMITATIONS TO THE PLT PARAMETER. THE DXH 800 SYSTEM MANAGER INCLUDES FLAGS, CODES, AND MESSAGES TO ALERT YOU TO ISSUES WITH PATIENT OR CONTROL RESULTS. YOU CAN ALSO CUSTOMIZE THE FLAGGING OF RESULTS AND DEFINE RULES FOR FLAGGING SAMPLE RESULTS. SUSPECT MESSAGES ARE GENERATED BY INTERNAL ALGORITHMS TO CONVEY THAT A CLINICAL CONDITION MAY EXIST WITH A SPECIMEN BASED ON AN ABNORMAL CELL DISTRIBUTION OR POPULATION. BECKMAN COULTER RECOMMENDS THE REVIEW OF RESULTS DISPLAYING A SUSPECT MESSAGE APPROPRIATE TO YOUR PATIENT POPULATION AND LABORATORY PRACTICE. BECKMAN COULTER, INC. DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN ALL SAMPLES. BECKMAN COULTER SUGGESTS USING ALL AVAILABLE OPTIONS TO OPTIMIZE THE SENSITIVITY OF INSTRUMENT RESULTS. THIS IS ONE OF 9 EVENTS REPORTED BY THIS CUSTOMER. THE RELATED MDRS ARE: 1061932-2012-00580, 1061932-2012-00581, 1061932-2012-00582, 1061932-2012-00583, 1061932-2012-00584, 1061932-2012-00585, 1061932-2012-00586, 1061932-2012-00587, 1061932-2012-00588.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TEST RESULTS FOR NUCLEATED RED BLOOD CELL COUNT (NRBC) OBTAINED FOR ONE SPECIFIC PATIENT USING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM (DXH 800) DID NOT AGREE WITH NRBC OBTAINED USING A MANUAL METHOD. IN ADDITION, REVIEW OF THE CUSTOMER'S DATA INDICATED THAT THE WHITE BLOOD CELL (WBC) COUNT OBTAINED USING THE DXH 800 WAS HIGHER THAN THE CUSTOMER'S CORRECTED WBC COUNT. THE PLATELET COUNT WAS ASSOCIATED WITH R (REVIEW) AND D (DELTA CHECK) FLAGS AND WAS HIGHER THAN THE PLATELET ESTIMATE OBTAINED USING A MANUAL BLOOD SMEAR. ERRONEOUS TEST RESULTS WERE NOT REPORTED OUT OF THE LABORATORY, WITH THE EXCEPTION OF THE PLATELET COUNT, WHICH WAS REPORTED. QUALITY CONTROL WAS PERFORMED BEFORE AND AFTER THE EVENT, AND WAS WITHIN SPECIFICATIONS. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, OR AFFECT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. DXH 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR