BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4C-ES CELL CONTROL

    MDR report key: 2172318 · Received June 24, 2011

    Report

    Report Number
    1061932-2011-00687
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    January 9, 2008
    Report Date
    January 10, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JPK
    PMA / PMN Number
    K010064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT LABELING STATES: "THIS SPECIMEN/REAGENT SHOULD BE HANDLED AT BIOSAFETY LEVEL 2, AS RECOMMENDED FOR ANY POTENTIALLY INFECTIOUS HUMAN SERUM OR BLOOD SPECIMEN IN THE CENTERS FOR DISEASE CONTROL/(B)(4) MANUAL "BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES, " 1988." THE FIELD SERVICE ENGINEER REPORTED USING THE ABNORMAL LOW CONTROL VIAL AT INITIAL OPENING OF THE VIAL TWO (2) DAYS PRIOR TO EVENT DATE AND VIALS WERE FINE. THE PRODUCT WAS DISCARDED BY THE CUSTOMER AND THEREFORE NOT AVAILABLE FOR EVALUATION. NO OTHER SIMILAR REPORTED EVENTS WITHIN THE PAST 12 MONTHS FOR THIS LOT NUMBER. ROOT CAUSE IS UNK. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POTENTIAL BIOHAZARD WHEN THE ABNORMAL LOW CONTROL VIAL OF 4C -ES CELL CONTROL WAS LEAKING FROM A CRACK AT THE TOP OF THE VIAL. OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE EVENT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4C-ES CELL CONTROL JPK BECKMAN COULTER, INC. NA 1686080K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COULTER ACT DIFF ANALYZER