BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGIL¿ PROTEIN CONTROL

    MDR report key: 2547293 · Received April 24, 2012

    Report

    Report Number
    2050010-2012-00014
    Event Type
    Malfunction
    Date Received
    April 24, 2012
    Date of Event
    March 29, 2012
    Report Date
    March 29, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJY
    PMA / PMN Number
    K982224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO HAVE RECEIVED A SHIPMENT OF VIGIL PROTEIN CONTROL L3 LOT# M104263 WITH 1 BOX OF CONTROL THAT HAD LEAKED. THE CUSTOMER WAS WEARING PROPER PPR CONSISTING OF GOWN, PROTECTION GLASSES AND GLOVES AT THE TIME OF THE EVENT. THE LEAKED FLUID CONTAINS MATERIAL OF HUMAN AND ANIMAL ORIGIN. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, EYE PROTECTION, AND GLOVES. THE CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID AND DID NOT SEEK MEDICAL ATTENTION. NO EXPOSURE (SPRAYED OR SPLASHED) TO MUCOUS MEMBRANES OR OPEN WOUNDS WERE REPORTED. NO DEATH, INJURY OR CHANGES TO PATIENT TREATMENT OR RESULTS ARE ASSOCIATED WITH THIS EVENT. THE TECHNICIAN DID NOT REFER TO THE MSDS (MATERIAL SAFETY DATA SHEETS), ALTHOUGH THE LABORATORY DOES HAVE AN EXPOSURE CONTROL PLAN. THE LABORATORY DID NOT RUN QC WITH THIS PRODUCT, AND NO ERRONEOUS RESULTS WERE GENERATED. THE ROOT CAUSE OF THE EVENT WAS A LOOSE CAP ON THE BOTTLE. A REPLACEMENT BOTTLE WAS SENT TO THE CUSTOMER. THE CUSTOMER WILL CALL BECKMAN COULTER INC. IF FURTHER ASSISTANCE IS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIGIL¿ PROTEIN CONTROL MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED) JJY BECKMAN COULTER, INC. VIGIL PROTEIN CONTROL M104263

    Patients

    Seq Age Sex Outcome Treatment
    1