BEUDAMED
    FDA Adverse Event Other Summary report: N

    VITROS 5.1 FS CHEMISTRY SYSTEM

    MDR report key: 850894 · Received May 16, 2007

    Report

    Report Number
    1319681-2007-00131
    Event Type
    Other
    Date Received
    May 16, 2007
    Date of Event
    April 16, 2007
    Report Date
    April 17, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT DETERMINED THAT THE CUSTOMER FOLLOWED OCD RECOMMENDED PROCEDURES FOR CHANGING THE LAMP. THE INVESTIGATION CONFIRMED THAT THE CIRCUIT BREAKER WAS TURNED OFF, REMOVING POWER FROM THE LAMP. THE CUSTOMER WAS WEARING NITRILE RUBBER GLOVES, AND DID NOT FEEL ANY HEAT. WHEN REMOVING THE GLOVES, THE SKIN FROM THE TIPS OF TWO FINGERS CAME OFF WITH THE GLOVE. PRELIMINARY INVESTIGATION HAS NOT REVEALED A HEAT SOURCE SUFFICIENT TO RESULT IN THE BURNS RECEIVED. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER RECEIVED SECOND DEGREE BURNS TO THE FOREFINGER AND THUMB WHEN CHANGING THE REFLECTOMETER LAMP ON THE VITROS 5.1 FS ANALYZER. THE CUSTOMER RECEIVED MEDICAL ATTENTION FOR THE BURNS AND WAS TREATED WITH BURN CREAM AND BANDAGES, AND HAS SINCE RETURNED TO FULL WORK RESPONSIBILITIES. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 5.1 FS CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR