BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER 5C CELL CONTROL

    MDR report key: 2183643 · Received July 8, 2011

    Report

    Report Number
    1061932-2011-00813
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    April 15, 2008
    Report Date
    April 15, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JPK
    PMA / PMN Number
    K912133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TWO LEVELS WITHIN THE KIT EXHIBITED THE LEAKAGE. THE OPEN VIAL CLAIM IS 13 TIMES WITHIN 13 DAYS. 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/NATIONAL INSTITUTES OF HEALTH MANUAL "BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES," 1988." CUSTOMER RETURN PRODUCT WAS NOT AVAILABLE FOR EVAL. COMPLAINT REVIEW WAS CONDUCTED. THERE WAS NO OTHER REPORTED EVENT FOR 5C CELL CONTROL VIALS LEAKING BETWEEN RUBBER STOPPER AND CAP WITHIN THE LAST 12 MONTHS. ROOT CAUSE IS UNK. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POTENTIAL BIOHAZARD WHEN THE VIALS IN THE COULTER 5C CELL CONTROL KIT WERE LEAKING BETWEEN THE RUBBER STOPPER AND THE CAP. LEAKAGE OCCURRED AFTER 3-4 PIERCES. OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AND 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 COULTER 5C CELL CONTROL JPK BECKMAN COULTER, INC. NA 1001093K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COULTER LH 500 HEMATOLOGY ANALYZER