BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2140116 · Received June 25, 2011

    Report

    Report Number
    1061932-2011-00762
    Event Type
    Malfunction
    Date Received
    June 25, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS WERE COLLECTED IN 3 ML EDTA VACUTAINER TUBES, STORED AT ROOM TEMPERATURE, AND PROCESSED WITH 2-4 HRS OF COLLECTION. RETIC CONTROLS (THREE LEVELS) WERE RUN AND WERE WITHIN QC SPECIFICATIONS FOR EACH DAY. RAW DATA FILES PROVIDED FOR THIS COMPLAINT INVESTIGATION DID NOT CONTAIN THE RETIC DATA (I.E. RETIC CYCLE) REQUIRED FOR ANALYSIS. SEVERAL ATTEMPTS WERE MADE TO OBTAIN THE ADDITIONAL INFORMATION NECESSARY FOR THE INVESTIGATION (I.E. RAW DATA, APPROPRIATE PRINTOUTS), BUT THE INFORMATION WAS NOT PROVIDED. SERVICE INFORMATION WAS REQUESTED BUT NOT PROVIDED. A DEFINITIVE ROOT CAUSE IS UNKNOWN FOR THIS EVENT. INSUFFICIENT INFORMATION WAS PROVIDED FOR THE INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT ONE (1) RETIC PATIENT SAMPLE RESULT OBTAINED ON THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM AND ALTERNATE INSTRUMENTS WERE NOT COMPARABLE. PER THE CUSTOMER, ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE INSTRUMENT PRINTOUT CORRESPONDING TO THE PATIENT SAMPLE WAS NOT PROVIDED. AS SUCH, FLAGS, MESSAGES, AND SCATTER PATTERNS COULD NOT BE EVALUATED FOR THE SAMPLE. THE PATIENT SAMPLE HAD A HIGHER RETIC VALUE WHEN RUN ON THE DXH800 IN COMPARISON TO THE ALTERNATE INSTRUMENT. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. DXH 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1