BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER ¿ COULTER ® LH750 HEMATOLOGY ANALYZER

    MDR report key: 2211050 · Received August 15, 2011

    Report

    Report Number
    1061932-2011-01177
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 13, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS DRAWN INTO BD EDTA TUBE. THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. FSE VERIFIED THE INSTRUMENT AND FOUND NO PROBLEMS. THE SAMPLES RUN BEFORE AND AFTER THE SAMPLE IN QUESTION LOOKED GOOD WITH NO IRREGULARITIES. RAW DATA ANALYSES: FOR THE HIGH EO RUN, ALL POPULATIONS SHIFTED TO THE RIGHT SIDE ON THE DF1 HISTOGRAM. SOME OF THE NEUTROPHILS WERE CLASSIFIED AS EOSINOPHILS BECAUSE OF THIS SHIFTING. DATA DISCONTINUITY WAS DETECTED DURING THE ASPIRATION, BUT THE ALGORITHM DID NOT SET A SYSTEM OR SUSPECT FLAG. ALL THREE RUNS WITH ELEVATED PLT RESULTS SHOWED LOW-END INTERFERENCE PATTERNS AND WERE FLAGGED R. ROOT CAUSE FOR THE ERRONEOUS DIFF WAS ALL POPULATIONS SHIFTED TO THE RIGHT SIDE ON THE DF1 HISTOGRAM AND SOME NEUTROPHILS WERE CLASSIFIED AS EOSINOPHILS. ALL THREE RUNS WITH ELEVATED PLT RESULTS SHOWED LOW-END INTERFERENCE PATTERNS AND WERE FLAGGED R. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) IN REGARDS TO AN ERRONEOUS HIGH EO AND LOW NE RESULTS WITHOUT ANY DIFF FLAGS ON ONE RUN (OUT OF FIVE) OF A PATIENT SPECIMEN WHEN COMPARED TO MANUAL DIFFERENTIAL. THREE ADDITIONAL RUNS OF THE SAME SPECIMEN ALSO GAVE ERRONEOUS HIGH PLT WITH INSTRUMENT GENERATED FLAGS AS COMPARED TO PLT ESTIMATE FROM SMEAR AND PATIENT HISTORY. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LAB. A MANUAL SMEAR WAS DONE BY A TECH AND CONFIRMED THE PLT RESULT OF 56. THE MANUAL DIFFERENTIAL RESULTS SHOWED LOWER EO%/HIGHER NE%. MANUAL DIFFERENTIAL AND PLT ESTIMATE WAS REPORTED AS CORRECT. NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT IS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER ¿ COULTER ® LH750 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. LH750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR