BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® 4C® PLUS CELL CONTROL

    MDR report key: 1943281 · Received December 31, 2010

    Report

    Report Number
    1061932-2010-00321
    Event Type
    Malfunction
    Date Received
    December 31, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JPK
    PMA / PMN Number
    K955016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE CUSTOMER'S QUALITY CONTROL FILE, THE VIAL HAD BEEN RUN 26 TIMES BEFORE THE FIRST LEAK AND 7 MORE TIMES BEFORE THE SECOND LEAK. THE CUSTOMER STOPPED USING THE VIAL ON (B)(6) 2010 AND THE PRODUCT WAS RETURNED FOR ANALYSIS. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A COULTER 4C PLUS CELL NORMAL CONTROL VIAL THAT LEAKED. THE VIAL LEAKED ON A TISSUE PAPER INSIDE THE REFRIGERATOR, AND NO OTHER AREAS WERE CONTAMINATED. THIS WAS SECOND TIME AFTER THE INCIDENT ON (B)(6) 2010 (MEDWATCH REPORT #1061932-2010-00318). THE CUSTOMER SUSPECTS THE CONTROL LEAKED OUT OF THE RUBBER CAP WHEN IT WAS INADVERTENTLY KNOCKED OVER SINCE IT HAD A LARGER THAN NORMAL PUNCTURE HOLE. AFTER EACH SPILL, THE CUSTOMER FOLLOWED THE LAB PROCEDURE TO CLEAN UP BIOHAZARD MATERIAL, WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT. IT IS UNKNOWN IF MSDS WAS REVIEWED, BUT IT IS AVAILABLE. NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS WAS REPORTED. NO ONE SOUGHT MEDICAL ATTENTION DUE TO THIS INCIDENT AND THERE WAS NO DEATH OR INJURY ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® 4C® PLUS CELL CONTROL HEMATOLOGY QUALITY CONTROL MIXTURE JPK BECKMAN COULTER, INC. NA 072300

    Patients

    Seq Age Sex Outcome Treatment
    1