BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER S-CAL CALIBRATOR

    MDR report key: 2339993 · Received November 4, 2011

    Report

    Report Number
    1061932-2011-02065
    Event Type
    Malfunction
    Date Received
    November 4, 2011
    Date of Event
    October 1, 2009
    Report Date
    October 1, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    KRY
    PMA / PMN Number
    K862122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN 01/01/2008 AND 10/23/2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. PRODUCT WAS REPLACED AT THE TIME OF THE EVENT. BASED UPON AVAILABLE INFO THE ROOT CAUSE IS UNK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN S-CAL CALIBRATOR VIAL LEAKING WHILE MIXING AND THE S-CAL CAP CAME OFF THE CONTAINER. THE OPERATOR WAS WEARING GLOVES AND LABORATORY SCRUB CLOTHING. THE CALIBRATOR SPILLED ON THE FLOOR, THE COUNTER AND THE CABINET DOORS AND ON THE FRONT OF THE CUSTOMER'S SCRUBS AND PANT LEGS. THE CUSTOMER WENT HOME TO CHANGE CLOTHES THEN HAD HER BLOOD DRAWN FOR POTENTIAL BIOHAZARD EXPOSURE TESTING. THE CUSTOMER STATED THAT SHE RECEIVED THE CALIBRATOR FROM ANOTHER FACILITY. THE OTHER FACILITY USED ONE VIAL OF CALIBRATOR AND SENT THE REMAINING VIA TO HER. THE CUSTOMER DID NOT INITIALLY OBSERVE ANY LEAKS FROM THE CALIBRATOR. THERE WAS NO EXPOSURE OF POTENTIAL BIOHAZARD TO MUCOUS MEMBRANES OR TO OPEN LESIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER S-CAL CALIBRATOR KRY BECKMAN COULTER, INC. NA 4717

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK