BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2151645 · Received June 24, 2011

    Report

    Report Number
    1061932-2011-00735
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    February 1, 2008
    Report Date
    February 1, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). FLAGGING SENSITIVITY WAS SET AT [2212], WHICH IS SET TO THE MID-LEVEL SETTING FOR ALL EXCEPT LOW LEVEL FOR IMM NE 1. SERVICE INFO WAS NOT PROVIDED. RAW DATA ANALYSIS WAS COMPLETED AND SHOWED ELONGATED OR LONG-TAIL NEUTROPHIL POPULATION. THE SOFTWARE ALGORITHM SET IMM NE 1 AND IMM NE 2 FLAGS BECAUSE OF THE ABDOMINAL PATTERN. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 1 OF 2 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 1061932-2011-00722.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS DIFFERENTIAL TEST RESULTS FOR ONE PT SAMPLE WHEN USING A COULTER LH 750 HEMATOLOGY ANALYZER. THERE WERE INSTRUMENT GENERATED FLAGS WITH THE TEST RESULTS. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS BASED ON TEST RESULTS FROM A COULTER GEN-S SYSTEM AND MANUAL DIFFERENTIAL RESULTS. ERRONEOUS TEST RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. 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 THE FIRST OF TWO 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 41 YR