BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3222789 · Received July 12, 2013

    Report

    Report Number
    1061932-2013-01353
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN 5 ML, EDTA COLLECTION TUBE AND WAS STORED AT ROOM TEMPERATURE FOR 2 HOURS. THE QUALITY CONTROLS (QC) WERE RUN BEFORE AND AFTER THE EVENT, AND ALL QC RESULTS WERE WITHIN SPECIFICATION. THE UNIT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). PER THE INFORMATION PROVIDED, THERE WAS NO CLUMPING SEEN ON THE SMEAR WHEN THE SMEAR WAS PREPARED. THE CUSTOMER INDICATED THAT THE TEMPERATURE IN THE LABORATORY WAS VERY COLD (65 DEGREES F), SUGGESTING THAT IT WAS LIKELY A PLT COLD AGGLUTININ. HOWEVER, THIS CAN NOT BE CONFIRMED. THE CUSTOMER TECHNICAL SPECIALIST (CTS) COLLECTED RAW DATA FOR THE EVENT; ANALYSIS IS PENDING. NO ONSITE SERVICE WAS DISPATCHED FOR THIS INCIDENT. FAILURE MODE OF THIS EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    BASED ON RAW DATA ANALYSIS, THE ERRONEOUS RUN WITH A PLATELET (PLT) VALUE OF 55 X 10^3 CELLS/L WAS NOT FLAGGED FOR CLUMP OR REVIEW. ALTHOUGH THERE WAS AN INDICATION OF A MINOR INTERFERENCE PATTERN IN THE FRONT OF THE WHITE BLOOD CELL (WBC) HISTOGRAM, THE MAGNITUDE OF INTERFERENCE WAS NOT SEVERE ENOUGH TO WARRANT AN R FLAG. FAILURE MODE: THERE WAS AN INDICATION OF A MINOR INTERFERENCE PATTERN FOR PLT ON THE WBC HISTOGRAM; HOWEVER, THE MAGNITUDE WAS NOT SEVERE ENOUGH TO TRIGGER AN R FLAG.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE UNICEL DXH 800 COULTER INSTRUMENT RECOVERED AN ERRONEOUS LOW PLATELET (PLT) VALUE ON THE INITIAL RUN FOR A SINGLE PATIENT COMPARED TO THE SAME SPECIMEN RUN LATER. THE ERRONEOUS RESULT WAS AUTO-VALIDATED AND REPORTED OUT OF THE LABORATORY. THE DOCTOR QUESTIONED THE RESULTS AND REQUESTED VERIFICATION OF THE PLT VALUE. UPON RERUN OF THE SAME PATIENT SPECIMEN, HIGHER PLT RESULTS WERE OBTAINED ON THE SAME DXH800 INSTRUMENT AND ON A SECOND DXH800 INSTRUMENT WHICH WAS CONSISTENT WITH MANUAL SMEAR ESTIMATE OBTAINED (CONSIDERED CORRECT). REVIEW OF THE INSTRUMENT PRINTOUTS FOR THE PATIENT CONFIRMED AN ERRONEOUS LOW PLT VALUE ON THE INITIAL RUN, WITH NO INSTRUMENT GENERATED FLAGS, WHEN COMPARED TO THE RERUN AND MANUAL SMEAR RESULTS. NO OTHER PARAMETERS WERE AFFECTED FOR THIS PATIENT. NO DEATH OR INJURY HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322130 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. DXH 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR