BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ® LH750

    MDR report key: 1842840 · Received September 23, 2010

    Report

    Report Number
    1061932-2010-00156
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 21, 2010
    Report Date
    September 23, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN 3ML EDTA TUBE, STORED AT ROOM TEMPERATURE AND PROCESSED WITHIN 1 HOUR OF COLLECTION. CONTROLS ARE RUN ONCE PER DAY AND WERE WITHIN ASSAY LIMITS PRE AND POST THE EVENT. A BCI FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED FOR THIS EVENT. RAW DATA WAS ANALYZED AND SHOWED 10% BLASTS AND 2% IMMATURE CELLS. THE ANALYSIS REVEALED THAT THE SCATTER PATTERNS SHOW A LITTLE ABNORMALITY, BUT THE SCATTER PATTERNS WERE NOT SIGNIFICANT ENOUGH FOR THE ALGORITHM TO TRIGGER BLAST FLAGS AT ANY SENSITIVITY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) STATING THAT THE COULTER LH 750 ANALYZER FAILED TO PROVIDE INSTRUMENT DIFFERENTIAL FLAGS ON A SAMPLE THAT WAS FOUND TO HAVE BLASTS BY MANUAL REVIEW. THE MANUAL DIFFERENTIAL INDICATED 10% BLASTS. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. NO DEATH, SERIOUS INJURY OR CHANGE TO PATIENT TREATMENT IS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ® LH750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1