BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® DXH CLEANER

    MDR report key: 1930945 · Received December 17, 2010

    Report

    Report Number
    1061932-2010-00292
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    October 15, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JCB
    PMA / PMN Number
    CL1 EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT REAGENT WAS SENT TO THE CUSTOMER. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO COULTER DXH CLEANER REAGENT THAT WAS LEAKING UPON RECEIVING. THE CUSTOMER WAS WEARING LAB COAT, GLOVES, AND EYE PROTECTION. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ONE REQUIRED MEDICAL ATTENTION AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® DXH CLEANER CLEANING AGENT JCB BECKMAN COULTER, INC. NA 2627880

    Patients

    Seq Age Sex Outcome Treatment
    1