BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENGEN LABORATORY AUTOMATION SYSTEM

    MDR report key: 1181043 · Received September 29, 2008

    Report

    Report Number
    1319681-2008-00288
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 4, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT DETERMINED THAT A MINOR INJURY (LACERATION) OCCURRED AS AN OCD FIELD ENGINEER WAS CLEANING A STAMPED METAL TUBE RACK HOLDER ON THE ENGEN LABORATORY AUTOMATED SYSTEM. THE LACERATION WAS TREATED, WITH NO APPARENT LONG TERM EFFECTS, PER LABORATORY PROCEDURES AT THE SITE THE FE WAS VISITING. THE FE WAS ALSO TREATED WITH ANTI-RETROVIRAL MEDICATION, WHICH CAN PRODUCE ADVERSE EVENTS. THE PATIENT IS BEING MONITORED BY AN INFECTIOUS DISEASE SPECIALIST FOR EVALUATION OF MEDICAL TREATMENT. ADDITIONAL LABORATORY TESTING WILL BE PERFORMED TO EVALUATE THE FE'S RISK OF INFECTION OR COMPLICATIONS. NO LONG TERM CONSEQUENCES ARE EXPECTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    AN ORTHO-CLINICAL DIAGNOSTICS FIELD ENGINEER REPORTED THAT HE RECEIVED A LACERATION ON HIS FINGER WHILE PERFORMING PREVENTIVE MAINTENANCE ON THE ENTRY/EXIT MODULE OF AN ENGEN LAB AUTOMATION SYSTEM. THIS IS AN AREA WHERE PATIENT SAMPLES ARE PROCESSED AND SERA CAN BE CONTACTED. EVENT OCCURRED AT THE HOSPITAL. THIS REPORT CORRESPONDS TO ORTHO-CLINICAL DIAGNOSTICS, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENGEN LABORATORY AUTOMATION SYSTEM LABORATORY AUTOMATION SYSTEM JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1