BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2211556 · Received August 5, 2011

    Report

    Report Number
    1061932-2011-01057
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    February 17, 2010
    Report Date
    February 19, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. RAW DATA ANALYSIS WAS CONDUCTED. THE DATA PATTERNS ASSOCIATED WITH THESE TWO SAMPLES DO NOT EXHIBIT A TYPICAL PATTERN FOR THE BLAST SAMPLES. ROOT CAUSE FOR THE MISSED BLAST FLAGGING IS THAT DUE TO HIGH LEVEL OF INTERFERENCE THE ALGORITHM COULD NOT IDENTIFY THE BLAST FEATURES. ROOT CAUSE FOR THE ERRONEOUS HIGH NRBC IS UNK. THE INSTRUMENT DID GENERATE AN R (REVIEW) SUSPECT FLAG WHICH ALERTS THE OPERATOR TO FURTHER REVIEW THE SPECIMEN. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 1 OF 3 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 1061932-2011-01058 AND MDR 1061932-2011-01059.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS DIFFERENTIAL TEST RESULTS AND ERRONEOUS HIGH NUCLEATED RED BLOOD CELLS (NRBC) WERE OBTAINED ON TWO PT SAMPLES WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS WHEN BLAST CELLS WERE IDENTIFIED ON MANUAL DIFFERENTIALS. THERE WERE NO INSTRUMENT GENERATED FLAGS FOR BLAST CELLS WITH THE AUTOMATED DIFFERENTIAL RESULTS. ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. THE TEST RESULTS WERE QUESTIONED BY THE PHYSICIAN AND THE MANUAL DIFFERENTIALS WERE PERFORMED. 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 3 EVENTS REPORTED BY THIS CUSTOMER OF ONE OF THREE ANALYZERS. THE INSTRUMENT WAS WITHIN QUALITY CONTROL SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). CONTROLS WERE RUN DAILY AND WERE RUN BEFORE THIS EVENT AND RECOVERED WITHIN ASSAY RANGES. FLAGGING PREFERENCES WERE SET TO 2202 WHICH IS MID-LEVEL FOR BLAST CELLS, VARIANT LYMPHOCYTES AND IMM. NE 2; AND SET TO OFF FOR IMM. NE 1, SENSITIVITY SETTING (3202) HIGH-LEVEL FOR BLAST CELLS, MID-LEVEL FOR VARIANT LYMPHOCYTES AND IMM. NE 2; AND SET TO OFF FOR IMM. NE1. THE SPECIMENS WERE RERUN AFTER THE CUSTOMER INCREASED THE INSTRUMENT FLAGGING SENSITIVITY, ONE SPECIMEN FLAGGED FOR LYOPHOBLASTS AND THE SECOND SPECIMEN DID NOT FLAG. 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.

    Additional Manufacturer Narrative · 2

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. RAW DATA ANALYSIS WAS CONDUCTED. THE DATA PATTERNS ASSOCIATED WITH THESE TWO SAMPLES DO NOT EXHIBIT A TYPICAL PATTERN FOR THE BLAST SAMPLES. ROOT CAUSE FOR THE MISSED BLAST FLAGGING IS THAT DUE TO HIGH LEVEL OF INTERFERENCE THE ALGORITHM COULD NOT IDENTIFY THE BLAST FEATURES. ROOT CAUSE FOR THE ERRONEOUS HIGH NRBC IS UNK. THE INSTRUMENT DID GENERATE AN R (REVIEW) SUSPECT FLAG WHICH ALERTS THE OPERATOR TO FURTHER REVIEW THE SPECIMEN. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 1 OF 3 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 1061932-2011-01058 AND MDR 1061932-2011-01059.

    Description of Event or Problem · 2

    CUSTOMER REPORTED ERRONEOUS DIFFERENTIAL TEST RESULTS AND ERRONEOUS HIGH NUCLEATED RED BLOOD CELLS (NRBC) WERE OBTAINED ON TWO PT SAMPLES WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS WHEN BLAST CELLS WERE IDENTIFIED ON MANUAL DIFFERENTIALS. THERE WERE NO INSTRUMENT GENERATED FLAGS FOR BLAST CELLS WITH THE AUTOMATED DIFFERENTIAL RESULTS. ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. THE TEST RESULTS WERE QUESTIONED BY THE PHYSICIAN AND THE MANUAL DIFFERENTIALS WERE PERFORMED. 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 3 EVENTS REPORTED BY THIS CUSTOMER OF ONE OF THREE ANALYZERS. THE INSTRUMENT WAS WITHIN QUALITY CONTROL SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). CONTROLS WERE RUN DAILY AND WERE RUN BEFORE THIS EVENT AND RECOVERED WITHIN ASSAY RANGES. FLAGGING PREFERENCES WERE SET TO 2202 WHICH IS MID-LEVEL FOR BLAST CELLS, VARIANT LYMPHOCYTES AND IMM. NE 2; AND SET TO OFF FOR IMM. NE 1, SENSITIVITY SETTING (3202) HIGH-LEVEL FOR BLAST CELLS, MID-LEVEL FOR VARIANT LYMPHOCYTES AND IMM. NE 2; AND SET TO OFF FOR IMM. NE1. THE SPECIMENS WERE RERUN AFTER THE CUSTOMER INCREASED THE INSTRUMENT FLAGGING SENSITIVITY, ONE SPECIMEN FLAGGED FOR LYOPHOBLASTS AND THE SECOND SPECIMEN DID NOT FLAG. 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.

    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 75 YR
    2 UNK