BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2433839 · Received January 31, 2012

    Report

    Report Number
    1061932-2012-00267
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Date of Event
    December 28, 2011
    Report Date
    January 3, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: PER RAW DATA ANALYSIS, ROOT CAUSE FOR THE DISCREPANCY IN MCV BETWEEN DXH 800 AND THE LH 500 INSTRUMENTS CANNOT BE DETERMINED. RAW DATA ANALYSIS.

    Description of Event or Problem · 1

    WHILE CONDUCTING AN INVESTIGATION AND INFORMATION GATHERING FOR MEDWATCH #1061932-2012-00155, A BEC FIELD AGENT FOUND EVIDENCE ON (B)(4) 2012 OF ERRONEOUS HIGH MEAN CORPUSCULAR VOLUME (MCV) GENERATED ON UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM WITH NO INSTRUMENT GENERATED FLAGS ON 6 SPECIFIC PATIENT SAMPLES WHICH WERE RUN ON THREE DIFFERENT DAYS. UPON REVIEW OF INSTRUMENT PRINTOUTS, IT WAS FOUND THAT FIVE OF SIX RED CELL DISTRIBUTION WIDTH (RDW) PATIENT RESULTS WERE ALSO ERRONEOUSLY HIGH AS COMPARED TO THE LH 500. CUSTOMER INDICATED THAT ALL 6 PATIENT SAMPLES WERE REPEATED ON THE LH 500 HEMATOLOGY ANALYZER ON THE SAME DAY THE ERRONEOUS RESULTS WERE GENERATED AND THE CORRECTED REPORTS WERE REPORTED OUT OF THE LAB. CUSTOMER STATED THAT NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND NO CHANGE TO PATIENT TREATMENT WAS ATTRIBUTED TO THIS EVENT. CUSTOMER REPORTED OF ONGOING ISSUES WITH THE DXH 800 GENERATING ERRONEOUS MCV VALUES ON SPECIFIC PATIENTS WHICH WERE NOT PASSING THE DELTA CHECK OF PATIENT RESULTS PRIOR TO IMPLEMENTATION OF THE UNIT. CUSTOMER INDICATED THAT OCCASIONALLY, THE RESULTS ALSO DISPLAY AN H&H (HEMOGLOBIN & HEMATOCRIT) CHECK FAILED MESSAGE. A SIMILAR EVENT WERE REPORTED BY CUSTOMER ON (B)(4) 2011 (MEDWATCH #1061932-2012-00155) AND THIS REPORT IS CREATED AS A RESULT OF AN INVESTIGATION FOR THAT EVENT. THIS REPORT IS FOR THE EVENT WHICH OCCURRED ON (B)(6) 2011. PLEASE SEE MEDWATCH #1061932-2012-00266 AND #1061932-2012-00268 FOR THE REPORT ON THE OTHER 5 PATIENTS. ERRONEOUS RESULTS OF 79.3 MCV AND 18.7 RDW WERE GENERATED FOR PATIENT 2 ON (B)(6) 2011 FROM THE DXH 800. THE SAMPLE WAS RERUN ON LH 500 AND RESULTS OF 74.9 MCV AND 17.2 RDW WERE OBTAINED. CUSTOMER DETERMINED THAT THE LH 500 RESULTS WERE CORRECT AND WERE REPORTED OUT OF THE LAB.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR