BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH700 SERIES DILUENT

    MDR report key: 2180998 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00656
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    April 28, 2010
    Report Date
    April 29, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GIF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTAINER HANDLE IS CREATED BY PERFORATED OPENINGS IN THE CORRUGATED CARDBOARD MATERIAL. THE CONTAINER HAS SIDE PANEL CUTOUTS FOR GRASPING AND PICKING UP THE PRODUCT. THESE CUTOUTS PROVIDE A SAFER CONFIGURATION FOR MOVING AND LIFTING BY EVENLY DISTRIBUTING THE WEIGHT OF THE CONTAINER FOR THE OPERATOR. THE CUSTOMER DID CONFIRM THAT THE PERSON LIFTING THE CONTAINER HAD PUT HER HANDS INTO THE INSERTS ON EITHER SIDE OF THE CONTAINER WHEN THE SIDE PERFORATION RIPPED. ROOT CAUSE IS UNK. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE HANDLE OF THE LH700 SERIES DILUENT BROKE WHEN THE CONTAINER WAS LIFTED. WHEN THE HANDLE BROKE, THE FOREARM OF THE PERSON LIFTING THE DILUENT CONTAINER STRUCK A COUNTERTOP. THE FORCE OF THE PERSON'S ARM IMPACTING THE COUNTERTOP RESULTED IN A BRUISE. FIRST AID WAS ADMINISTERED WHEN ICE WAS PLACED ON THE BRUISE. MEDICAL ATTENTION WAS NOT SOUGHT. NO REPORTS OF DEATH OR SERIOUS INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LH700 SERIES DILUENT GIF BECKMAN COULTER, INC. NA 510281

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COULTER LH 780 HEMATOLOGY ANALYZER