BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4C -ES CELL CONTROL

    MDR report key: 2175321 · Received June 15, 2011

    Report

    Report Number
    1061932-2011-00571
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    October 13, 2008
    Report Date
    October 13, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JPK
    PMA / PMN Number
    K010064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER INC. PRODUCT LABELING STATES THAT PPE MUST BE WORN WHEN HANDLING THE PRODUCT. SPECIFICALLY, 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 (B)(6) MANUAL "BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES," 1988. CUSTOMER CANCELED A PLANNED FIELD SERVICE VISIT TO EVALUATE THE ANALYZER BECAUSE THE OTHER CONTROL VIALS DID NOT LEAK. THE PRODUCT WAS USED FOR APPROX 15 PIERCES BEFORE IT LEAKED. THE OPEN VIAL CLAIM IS THAT THE PROCEDURE LISTED IN THE INSTRUCTIONS FOR USE CAN BE PERFORMED A MAXIMUM OF 20 TIMES WITHIN 35 DAYS. ROOT CAUSE FOR THE FAILURE OF THE VIAL STOPPER WAS NOT DETERMINED. 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 A POTENTIAL BIOHAZARD EVENT WHEN A NORMAL CONTROL VIAL OF 4C -ES CELL CONTROL LEAKED FROM THE CAP WHEN USING A COULTER AC-T DIFF 2 ANALYZER ON (B)(6) 2008. THE OPERATOR WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT. THE OPERATOR WAS EXPOSED TO THE CONTROL MATERIAL, HOWEVER, THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. 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 079200

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COULTER AC-T DIFF 2 ANALYZER