BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2256831 · Received August 19, 2011

    Report

    Report Number
    1061932-2011-01170
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    March 31, 2010
    Report Date
    April 5, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS WITHIN QUALITY CONTROL (QC) SPECS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). CONTROLS WERE RUN EACH SHIFT AND PT CONTROLS WERE RUN 2 TO 3 TIMES DURING EACH SHIFT AND RECOVERED WITHIN ASSAY RANGES. FLAGGING PREFERENCES ARE SET TO (2202), WHICH IS MID-LEVEL FOR BLAST, VARIANT LYMPHOCYTES AND IMM. NE 2; AND OFF FOR IMM NE 1. THE OPERATOR INCREASED THE BLAST SENSITIVITY TO MID LEVEL FOR BLAST ON THE ANALYZER AND RERAN THE SPECIMEN. NO INSTRUMENT FLAG WAS GENERATED. RAW DATA FILES WERE NOT AVAILABLE FOR ANALYSIS. NOTE: IMM NE 1 IS A FLAG FOR SUSPECT IMMATURE NEUTROPHILS, PRIMARILY BANDS. IMM NE 2 IS A FLAG FOR SUSPECT IMMATURE NEUTROPHILS, PRIMARILY METAMYELOCYTES, MYELOCYTES, AND PROMYELOCYTES. SERVICE INFO IS NOT AVAILABLE. RAW DATA WAS NOT AVAILABLE FOR ANALYSIS. ROOT CAUSE FOR THE MISSED BLAST FLAGGING IS UNK. AN INSTRUMENT GENERATED FLAG FOR IMM NE 1 MAY HAVE BEEN GENERATED, IF THE FLAGGING PREFERENCES WERE NOT SET TO "OFF" FOR THE IMM NE 1 FLAG. PRODUCT LABELING INDICATES THE USE OF ALL AVAILABLE FLAGGING OPTIONS TO OPTIMIZE THE SENSITIVITY OF THE INSTRUMENT RESULTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 2 OF 2 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO MDR 1061932-2011-01169.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS DIFFERENTIAL RESULTS WERE OBTAINED FOR ONE PT WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE TEST RESULTS WERE NOT ASSOCIATED WITH AN INSTRUMENT GENERATED DIFFERENTIAL FLAG FOR THE PRESENCE OF BLAST CELLS. ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS WHEN COMPARED TO A MANUAL DIFFERENTIAL CONTAINING 61% BLAST CELLS. A CORRECTED REPORT WAS ISSUED. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 2 OF 2 EVENTS REPORTED BY THIS CUSTOMER FOR TWO DIFFERENT ANALYZERS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR