BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LIN-X LINEARITY CONTROL

    MDR report key: 2281682 · Received September 30, 2011

    Report

    Report Number
    1061932-2011-01571
    Event Type
    Malfunction
    Date Received
    September 30, 2011
    Date of Event
    March 17, 2009
    Report Date
    March 20, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JPK
    PMA / PMN Number
    K081641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. THIS EVENT OCCURRED IN THE PREMISES OF BECKMAN COULTER (MIAMI LAKES TRAINING CENTER). SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE ROOT CAUSE FOR THE VIAL LEAKING IS UNKNOWN. HOWEVER, THE PACKAGING ENGINEERING DEPARTMENT REVIEWED AND INSPECTED THE CAPPING/TORQUING PROCESS. IT WAS FOUND THAT THE HEMATOLOGY FILL/CAP/LABEL LINE IS UNDER CONTROL AND THE IN-PROCESS TORQUE REMOVAL TESTS WERE WITHIN VALIDATED SPECIFICATION. RESULTS ALSO SHOWED THAT THE VIALS TESTED COULD BE ADDITIONALLY TIGHTENED 1/4 TO 1/2 TURN IN ORDER TO SECURE THE CAPS FURTHER ALTHOUGH THE CURRENT TORQUE IS WITHIN NORMAL SPECIFICATION. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    POTENTIAL BIOHAZARD EXPOSURE WAS REPORTED; WHILE PERFORMING LINEARITY STUDIES THE OPERATOR WAS MIXING THE COULTER LIN-X LINEARITY CONTROL, AS PER LABELING INSTRUCTIONS, WHEN THE CAP CAME OFF THE VIAL AND THE CONTROL MATERIAL SPILLED OUT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LAB COAT AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS AND MEDICAL ATTENTION WAS NOT SOUGHT. IT IS UNKNOWN IF THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED, HOWEVER, IT IS READILY AVAILABLE. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT. THE SPILLED AREA WAS DISINFECTED AND CLEANED UP ACCORDING TO LABORATORY PROTOCOLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LIN-X LINEARITY CONTROL JPK BECKMAN COULTER, INC. NA 2433780K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DXH 800 HEMATOLOGY SYSTEM