BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2218158 · Received August 22, 2011

    Report

    Report Number
    1061932-2011-01094
    Event Type
    Malfunction
    Date Received
    August 22, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF CUSTOMER PROVIDED DATA INDICATED THAT THE PATIENT SAMPLE EXHIBITED ABNORMAL LYMPHOCYTE POPULATIONS ON THE HISTOGRAMS. BECAUSE OF THE ABNORMAL PATTERNS, THE ALGORITHM SET BLAST FLAGS AT ALL SENSITIVITY LEVELS FOR THE SECOND RUN (B)(4). HOWEVER, FOR THE FIRST RUN (B)(4), IT SET A BLAST FLAG ONLY AT THE HIGHEST SENSITIVITY. THE INSTRUMENT DID, HOWEVER, GENERATE AN IMM NE 1 SUSPECT MESSAGE TO ALERT THE OPERATOR TO FURTHER REVIEW THE DIFFERENTIAL RESULTS. BECKMAN COULTER INC. RECOMMENDS THAT THE HIGHEST SENSITIVITY SETTING FOR BLAST FLAGGING BE USED. SERVICE WAS DISPATCHED TO THE SITE ON (B)(6) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) PERFORMED FLOW CELL ADJUSTMENT, LASER ALIGNMENT, AND REPLACED/REPAIRED VALUES. VCS OPTIMIZATION WAS VERIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 THE COULTER LH 750 HEMATOLOGY ANALYZER INSTRUMENT DID NOT GENERATE A BLAST FLAG FOR A PATIENT SPECIMEN OBTAINED FROM A KNOWN ONCOLOGY PATIENT WITH ACUTE LYMPHOCYTIC LEUKEMIA. THE INSTRUMENT DID, HOWEVER, GENERATE AN IMM NE 1 SUSPECT MESSAGE. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY HOWEVER WERE QUESTIONED BY THE PHYSICIAN AS THEY DID NOT ALIGN WITH THE PATIENT'S CLINICAL PICTURE. THE PHYSICIAN REQUESTED THE EXECUTION OF A MANUAL SMEAR. THE MANUAL SMEAR RESULTS REVEALED OVER 50% LYMPHOBLASTS. ANOTHER PATIENT SAMPLE WAS DRAWN THE FOLLOWING DAY. REPEAT RESULTS ON THE SAME INSTRUMENT GENERATED INSTRUMENT LY BLASTS AND IMM NE1 MESSAGES. THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. QUALITY CONTROLS EXECUTED TWELVE HOURS PRIOR TO THE EVENT AND TWO HOURS AFTER THE EVENT GENERATED RESULTS WITHIN ESTABLISHED SPECIFICATIONS. THE INSTRUMENT'S FLAGGING SENSITIVITY SETTINGS AT THE TIME OF THE EVENT WERE SET AT 2222, WHERE THE BLASTS, VARIANT LYMPH, IMM NE1, IMM NE 2, WERE ALL SET AT MID LEVEL. THE SAMPLE WAS STORED AT ROOM TEMPERATURE, AND PROCESSED WITHIN ONE HOUR OF SPECIMEN COLLECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR