BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2151520 · Received June 24, 2011

    Report

    Report Number
    1061932-2011-00722
    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 SPECS 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. RAW DATA ANALYSIS WAS COMPLETED FOR DATA RECEIVED FOR ONE OF THE TWO SAMPLES (ID (B)(6)). THE DATA ANALYSIS SHOWED ELONGATED OR LONG-TAIL NEUTROPHIL POPULATION. THE SOFTWARE ALGORITHM SET IMM NE 1 AND IMM NE 2 FLAGS BECAUSE OF THE ABNORMAL PATTERN. ROOT CAUSE FOR THE OTHER SAMPLE COULD NOT BE DETERMINED BECAUSE DATA WAS NOT RECEIVED. 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 1061932-2011-00735.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS DIFFERENTIAL TEST RESULTS FOR TWO PT SAMPLES WHEN USING A COULTER LH 750 HEMATOLOGY ANALYZER. THERE WERE NO INSTRUMENT GENERATED FLAGS FOR THE PRESENCE OF BLAST CELLS FOR ONE OF THE TWO PT SAMPLES. 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 1 OF 2 EVENTS REPORTED BY THIS CUSTOMER FOR THE FIRST OF TWO ANALYZERS.

    Additional Manufacturer Narrative · 2

    THE INSTRUMENT WAS WITHIN QC SPECS 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 FOR DATA RECEIVED FOR ONE OF THE TWO SAMPLES (ID (B)(6)). THE DATA ANALYSIS SHOWED ELONGATED OR LONG-TAIL NEUTROPHIL POPULATION. THE SOFTWARE ALGORITHM SET IMM NE 1 AND IMM NE 2 FLAGS BECAUSE OF THE ABNORMAL PATTERN. ROOT CAUSE FOR THE OTHER SAMPLE COULD NOT BE DETERMINED BECAUSE DATA WAS NOT RECEIVED. 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 1061932-2011-00735.

    Description of Event or Problem · 2

    CUSTOMER REPORTED ERRONEOUS DIFFERENTIAL TEST RESULTS FOR TWO PT SAMPLES WHEN USING A COULTER LH 750 HEMATOLOGY ANALYZER. THERE WERE NO INSTRUMENT GENERATED FLAGS FOR THE PRESENCE OF BLAST CELLS FOR ONE OF THE TWO PT SAMPLES. 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 1 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 LH750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR
    2 41 YR