BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ® LH750

    MDR report key: 1917556 · Received December 8, 2010

    Report

    Report Number
    1061932-2010-00265
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) CHECKED SAFETY SWITCHES AND LOCKS AND REPORTED THE UNIT IS IN OPERATIONAL. FSE ORDERED NEW NEEDLE. ROOT CAUSE FOR THIS EVENT MAY BE ATTRIBUTED TO THE OPERATORS HANDLING OF THE NEEDLE CARTRIDGE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN OPERATOR'S LEFT INDEX FINGER BEING PUNCTURED BY THE NEEDLE WHILE PLACING THE NEEDLE CARTRIDGE IN AFTER CLEANING THE AREA. THE INSTRUMENT IN THIS EVENT WAS COULTER LH 750 ANALYZER. THE OPERATOR WAS WEARING PROPER PPE, BUT DID NOT USE THE SAFETY RED CLIP TO REMOVE THE NEEDLE CARTRIDGE, AS PER LABELING. THE OPERATOR SOUGHT MEDICAL ATTENTION AND GOT A TETANUS SHOT AND BLOOD TEST FOR HIV AND HEPATITIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention