BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2437000 · Received February 2, 2012

    Report

    Report Number
    1061932-2012-00297
    Event Type
    Malfunction
    Date Received
    February 2, 2012
    Date of Event
    December 26, 2011
    Report Date
    January 10, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INFORMATION PROVIDED, QC HAS BEEN PERFORMING WELL. SERVICE INFORMATION WAS REQUESTED, BUT HAS NOT BEEN SUPPLIED. ANALYSIS OF RAW DATA FILES PROVIDED FOR TWO SAMPLES TESTED ON SN (B)(4) INDICATES THAT PROVIDED SAMPLE HAS 20% BLASTS, ACCORDING TO THE MANUAL COUNT. THE HISTOGRAMS SHOW SLIGHTLY ABNORMAL PATTERNS. ALTHOUGH THE NEUTROPHIL AND MONOCYTE POPULATIONS ARE TOUCHING AND ARE BOTH SLIGHTLY ELONGATED, THEY WERE NOT CRITICAL ENOUGH TO SET FLAGS. THE ALGORITHM DID NOT SET BLAST FLAGS BECAUSE PATTERNS PRODUCED ARE NOT SIGNIFICANTLY ABNORMAL FOR A BLAST SAMPLE. REVIEW OF THE RAW DATA ALSO INDICATED DAY-TO-DAY SAMPLE VARIABILITY BETWEEN THE NEUTROPHIL, LYMPHOCYTES AND MONOCYTE DIFFERENTIAL POPULATIONS. THE REASON FOR THIS VARIABILITY IS UNKNOWN. THE ROOT CAUSE FOR THE INCONSISTENT BLAST FLAGGING IS UNKNOWN. HOWEVER, INSTRUMENT-GENERATED FLAGS/MESSAGES WERE PROVIDED FOR SEVEN OF THE ELEVEN SAMPLES ON SN (B)(4) TO ALERT THE OPERATOR TO REVIEW THE DIFFERENTIAL RESULTS. ADDITIONALLY, INSTRUMENT-GENERATED FLAGS/MESSAGES WERE PROVIDED FOR ELEVEN OF THE FOURTEEN SAMPLES FOR INSTRUMENT, SN (B)(4). PER LABELING, BECKMAN COULTER INC., (BEC) DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN ALL SAMPLES. BEC SUGGESTS USING ALL AVAILABLE OPTIONS TO OPTIMIZE THE SENSITIVITY OF INSTRUMENT RESULTS. ALL MESSAGES, SYSTEM MESSAGES, SUSPECT MESSAGES, STATUS AND EXCEPTION MESSAGES. THE FOLLOWING MDRS ARE BEING SUBMITTED FOR THIS ISSUE FROM THIS ACCOUNT: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMS (SN (B)(4)) - 1061932-2012-00284, 1061932-2012-00285, 1061932-2012-00286, 1061932-2012-00287, 1061932-2012-00288, 1061932-2012-00289, 1061932-2012-00290, 1061932-2012-00291. UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMS (SN (B)(4)) - 1061932-2012-00292, 1061932-2012-00293, 1061932-2012-00294, 1061932-2012-00295, 1061932-2012-00296, 1061932-2012-00297, 1061932-2012-00298, 1061932-2012-00299, 1061932-2012-00300, 1061932-2012-00301, 1061932-2012-00302, 1061932-2012-00303, 1061932-2012-00304.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED THAT TWO (2) UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMS (SNS (B)(4)) FAILED TO CONSISTENTLY PROVIDE BLAST FLAGGING FOR A SINGLE PATIENT WITH A HISTORY OF MYELODYSPLASTIC SYNDROME AND BLASTS IDENTIFIED BY MORPHOLOGICAL REVIEW. INSTRUMENT PRINTOUTS WERE PROVIDED FOR SEVERAL SAMPLES OBTAINED FROM (B)(6) 2011 - (B)(6) 2012, FROM BOTH INSTRUMENTS, FOR THIS PATIENT. MANUAL SMEAR RESULTS WERE REQUESTED FOR ALL SAMPLES, BUT WERE ONLY PROVIDED FOR SELECT SAMPLES (BEGINNING (B)(6) 2012). AS SUCH, THE REMAINING SAMPLES (FROM (B)(6) 2011) COULD NOT BE ASSESSED FOR FALSE NEGATIVE BLAST FLAGGING. THIS REPORT IS FOR THE PATIENT SAMPLE TESTED ON THE UNICEL DXH 800, SN (B)(4), ON (B)(6) 2011. THE INSTRUMENT PRINTOUT CONTAINED INSTRUMENT-GENERATED DIFFERENTIAL FLAGS/MESSAGES, BUT NO BLAST-SPECIFIC FLAGS/MESSAGES. THERE IS NO DEATH OR INJURY ASSOCIATED WITH THIS COMPLAINT. IT IS UNKNOWN IF THERE HAS BEEN ANY AFFECT TO PATIENT TREATMENT.

    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 59 YR