BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 13871090 · Received March 23, 2022

    Report

    Report Number
    1319681-2022-00013
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    February 24, 2022
    Report Date
    March 23, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED AN ORTHO FIELD ENGINEER (FE) SUSTAINED A MINOR CUT TO THE MIDDLE FINGER OF HIS RIGHT HAND WHEN WORKING TO THE REAR OF THE MOTION CONTROLLER AND POWER TRANSFORMER ON A VITROS 5600 INTEGRATED SYSTEM. THE ORTHO FE WAS WEARING GLOVES AT THE TIME OF THE EVENT BUT DID NOT UNDERTAKE ANY BASIC MEDICAL FIRST AID SUCH AS WASHING THE CUT AND APPLYING A BAND AID AT THE TIME OF THE EVENT AND CONTINUED WORKING. THIS HAS RESULTED IN AN INFECTION OF THE FINGER REQUIRING A MINOR MEDICAL PROCEDURE. THE MOST LIKELY ASSIGNABLE CAUSE OF THIS EVENT IS USER ERROR AND FAILURE TO FOLLOW GOOD LABORATORY PRACTICE. (B)(4).

    Description of Event or Problem · 0

    THE INVESTIGATION DETERMINED AN ORTHO FIELD ENGINEER (FE) SUSTAINED A MINOR CUT TO THE MIDDLE FINGER OF HIS RIGHT HAND WHEN WORKING TO THE REAR OF THE MOTION CONTROLLER AND POWER TRANSFORMER ON A VITROS 5600 INTEGRATED SYSTEM. BASED ON A MEDICAL CONSULT WITH ORTHO MEDICAL SAFETY OFFICER, DR (B)(4) ON 16 MARCH 2022 REGARDING THIS EVENT, IT WAS DEEMED CONSISTENT WITH A MINOR CUT AND NOT A SERIOUS INJURY. IT IS UNLIKELY THERE WOULD BE ANY PERMANENT IMPACT TO THE FUNCTION OF THE FINGER OR THE RIGHT HAND DUE TO THIS INCIDENCE AND AS SUCH THE EVENT IS NOT REPORTABLE. THE INCIDENT HAS BEEN REPORTED LOCALLY AS AN OCCUPATIONAL ACCIDENT AND A MINOR SURGICAL INTERVENTION WAS PERFORMED, WITH AN ABUNDANCE OF CAUTION. THE ORTHO COMPLAINT HANDLING UNIT HAS TAKEN THE DECISION TO CONSERVATIVELY REPORT THIS EVENT. THE ORTHO FE IS REPORTED TO BE RECOVERING WELL AND THERE ARE NO ANTICIPATED LONG-TERM EFFECTS FROM THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950563 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown