BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 2883732 · Received December 21, 2012

    Report

    Report Number
    1226181-2012-00168
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K944093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS INSTRUCTOR WAS AT THE COMPANY SITE CONDUCTING NEW USER TRAINING. FILM FROM A CARTRIDGE FELL OFF THE CUVETTE WHEEL AND INTO THE THERMAL CHAMBER DURING THIS DEMONSTRATION. THE ASSOCIATE POWERED THE SYSTEM DOWN AND PUT HIS LEFT HAND INTO THE THERMAL CHAMBER TO DISLODGE THE FILM. HIS HAND HIT SOMETHING SHARP AT THE TOP OF THE THERMAL CHAMBER CAUSING A LACERATION ON THE LEFT HAND MIDDLE KNUCKLE. THE INSTRUCTOR WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE EVENT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A SIEMENS ASSOCIATE WAS INJURED WHILE CONDUCTING NEW USER TRAINING ON HOW TO REPLACE THE CUVETTE FILM CARTRIDGE ON THE DIMENSION EXL WITH LM SYSTEM. THE EMPLOYEE WENT TO EMPLOYEE HEALTH SERVICES AND WAS SUBSEQUENTLY SENT TO A LOCAL URGENT CARE FACILITY FOR TREATMENT. THE ASSOCIATE HAD A FOLLOW-UP VISIT WITH A PHYSICIAN 9 DAYS FOLLOWING THE EVENT AND WAS ALLOWED TO RETURN TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION EXL WITH LM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other