BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2171249 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00755
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    February 17, 2008
    Report Date
    February 20, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS WITHIN QUALITY CONTROL (QC) SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. CONTROLS WERE RUN ONCE PER SHIFT. CONTROLS WERE RUN BEFORE AND AFTER THIS INCIDENT. THE SYSTEM SENSITIVITY WAS SET AT 2202, WHICH IS MID-LEVEL FOR FLAGGING, EXCEPT IT WAS SET TO OFF FOR IMM NE 1. NOTE: IMM NE 1 IS A FLAG FOR SUSPECT IMMATURE NEUTROPHILS, PRIMARILY BANDS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. AS OF (B)(4) 2008, NO OTHER PATIENT RESULTS HAVE EXHIBITED THIS PROBLEM. RAW DATA ANALYSIS WAS CONDUCTED FOR TWO DATA FILES RECEIVED FOR THIS PATIENT (LIST NAME (B)(4)). BOTH SHOW SMALL AND DENSE NEUTROPHIL POPULATIONS. THEY ALSO HAVE TAILS CONSISTENT WITH SCATTERED EVENTS FROM THE MAIN POPULATION TO THE HIGHER DC END. DUE TO THE DENSE AND TIGHT MAIN NEUTROPHIL POPULATION WHICH IS TYPICALLY NORMAL FOR NEUTROPHIL POPULATIONS, THE ALGORITHM DID NOT GENERATE BLAST FLAG FOR THIS SAMPLE. THE SCATTERED TAIL CAN BE BLAST CELL EVENTS, BUT SIMILAR PATTERNS CAN BE OBSERVED FROM AGING OR NOISY SAMPLES. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 3 OF 6 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED. MDR 1061932-2011-00753, 1061932-2011-00754, 1061932-2011-00757, 1061932-2011-00758, 1061932-2011-00759.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS DIFFERENTIAL RESULTS OBTAINED FOR ONE PATIENT WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. CUSTOMER PERFORMED MANUAL BLOOD SMEAR DIFFERENTIAL PER LABORATORY PROTOCOL. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS WHEN COMPARED TO A MANUAL DIFFERENTIAL THAT CONTAINED BLAST CELLS. THE AUTOMATED DIFFERENTIAL RESULTS DID NOT CONTAIN INSTRUMENT GENERATED FLAGS FOR BLAST CELLS. ERRONEOUS TEST RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 3 OF 6 EVENTS REPORTED BY THIS CUSTOMER FOR THIS PATIENT. SAMPLES FROM THIS PATIENT WERE TESTED OVER SEVERAL DAYS. THIS EVENT IS FOR SAMPLE TESTED ON (B)(6) 2008, DAY SHIFT.

    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 UNK