BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® FOLATE CALIBRATORS

    MDR report key: 2473462 · Received February 29, 2012

    Report

    Report Number
    2122870-2012-00553
    Event Type
    Malfunction
    Date Received
    February 29, 2012
    Date of Event
    February 6, 2012
    Report Date
    February 6, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGN
    PMA / PMN Number
    K955434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THE DEVICE WAS RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DAMAGED FLOW CALIBRATOR VIAL WAS RECEIVED INVOLVING ACCESS FOLATE CALIBRATORS. THE CUSTOMER STATED THE BOTTOM OF THE VIAL WAS BROKEN. THE BOX CONTAINER WAS NOT DAMAGED. THE CUSTOMER HAD ON APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE EVENT. PATIENT RESULTS WERE NOT IMPACTED. THERE WAS NO EXPOSURE TO OPEN LESIONS OR MUCUS MEMBRANES. THERE WAS NO REPORT OF INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. BECKMAN COULTER, INC. SENT A REPLACEMENT KIT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® FOLATE CALIBRATORS ACID, FOLIC, RADIOIMMUNOASSAY CGN BECKMAN COULTER, INC. NA 116144

    Patients

    Seq Age Sex Outcome Treatment
    1