BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® FOLATE CALIBRATORS

    MDR report key: 2502652 · Received March 23, 2012

    Report

    Report Number
    2122870-2012-00897
    Event Type
    Malfunction
    Date Received
    March 23, 2012
    Date of Event
    February 29, 2012
    Report Date
    February 29, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGN
    PMA / PMN Number
    K955434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THE DEVICE WAS RETURNED FOR EVALUATION. THE CAUSE OF THE EVENT IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE CALIBRATOR VIALS CRACKED AND LEAKED CONTENTS INVOLVING ACCESS FOLATE CALIBRATORS. THE CUSTOMER NOTICED THE VIALS WERE CRACKED AND LEAKING DURING THAWING OF THE FOLATE CALIBRATORS. THE CUSTOMER STATED THERE WERE "SMALL PUDDLES" UNDER EACH VIAL OF THE CALIBRATOR. THE CUSTOMER CONTAINED ALL LEAKAGE. THERE WAS NO EVIDENCE OF DAMAGE TO THE KIT BOX. THE CUSTOMER STATED THERE WAS NO EXPOSURE TO THE LEAK CONTENTS AND CLEANED UP THE LEAK PER THE LABORATORY PROCEDURE IN PLACE. THERE WAS NO REPORT OF INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) SENT THE CUSTOMER THE REPLACEMENT FOLATE CALIBRATOR KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® FOLATE CALIBRATORS ACID, FOLIC, RADIOIMMUNOASSAY CGN BECKMAN COULTER, INC. NA 112788

    Patients

    Seq Age Sex Outcome Treatment
    1