BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM EVOLYZER 2 150

    MDR report key: 23438382 · Received October 31, 2025

    Report

    Report Number
    3003402518-2025-00001
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    September 26, 2025
    Report Date
    October 30, 2025
    Manufacturer
    TECAN SCHWEIZ AG
    Product Code
    JQW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE PERFORMED AS INTENDED. THE FREEDOM EVOLYZER IS DESIGNED TO ALLOW FOR ACCESS TO THE WORKTABLE FOR CONTINUOUS LOADING, AS REQUIRED FOR CERTAIN LABORATORY WORKFLOWS. USER INTERACTION IS ALSO ALLOWED BY STOPPING WHEN AN ERROR MESSAGE APPEARS. THE SYSTEM WILL ONLY RESTART AFTER THE USER PRESSES THE KEYPAD BUTTON TO CONFIRM THE RESUMPTION OF THE INTERRUPTED ACTION. INVESTIGATION INTO THIS COMPLAINT INCLUDED A SUPPORTING INFORMATION REVIEW AND COMPLAINT HISTORY REVIEW. THE RESULTS OF THE INVESTIGATION ARE SUMMARIZED AS FOLLOWS: SUPPORTING INFORMATION REVIEW: FREEDOM EVOLYZER USER MANUAL, DOC ID 393035, REVISION 2.10 WAS REVIEWED. REVIEW CONCLUDED THAT OPERATIONAL AND SAFETY WARNINGS ARE PROVIDED THROUGHOUT THE MANUAL TO ENSURE THAT SUCH ACCESS IS PERFORMED SAFELY AND ONLY WHEN THE INSTRUMENT IS NOT IN OPERATION: CHAPTER 2.3 "SAFETY", CHAPTER 6.3.1 "SAFETY INSTRUCTION AND WARNING SYMBOL ON FRONT SAFETY PANEL". CHAPTER 6.1 "OPERATING AND DISPLAY ELEMENTS" DESCRIBES THE STATUS SIGNALS OF THE LEDS ON THE WORKTABLE. COMPLAINT HISTORY REVIEW: A COMPLAINT SEARCH WAS PERFORMED TO IDENTIFY PAST PRE (POTENTIAL REPORTABLE EVENT) COMPLAINT TICKETS FOR ANY INSTANCES WHERE A USER OF THE FREEDOM EVOLYZER SUSTAINED A SCRATCH WOUND TO THEIR FINGER THROUGH PPE GLOVES WHILE CARRYING OUT INSTRUMENT MAINTENANCE OR OPERATION. COMPLAINT HISTORY REVIEW SHOWED THAT, IN THE PAST FIVE YEARS THE ELEVATED COMPLAINT TICKET UNDER CURRENT INVESTIGATION WAS THE ONLY COMPLAINT RELATED TO PERSONAL INJURY ON THE FREEDEOM EVOLYZER. BASED ON THE RESULTS OF THE INVESTIGATION, A PRODUCT DEFICIENCY WAS NOT IDENTIFIED FOR THE FREEDOM EVOLYZER. THE INCIDENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. NOTE: THIS REPORT OR OTHER INFORMATION SUBMITTED BY TECAN UNDER 21CFR PART 803, AND ANY RELEASE BY FDA OF THAT REPORT OR INFORMATION, DOES NOT REFLECT A CONCLUSION BY TECAN OR FDA THAT THE REPORT OR INFORMATION CONSTITUTES AN ADMISSION THAT THE DEVICE, TECAN, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2025 TECAN SWITZERLAND WAS MADE AWARE THAT THE LABORATORY REPORTED DURING ROUTINE OPERATION THE FREEDOM EVOLYZER INSTRUMENT GAVE AN ALERT, AND THE TECHNICIAN RESTARTED THE INSTRUMENT WITH THEIR HAND STILL INSIDE. AS A RESULT, THE NEEDLE SCRATCHED THE TOP OF THE TECHNICIAN'S HAND AND PIERCED THE GLOVE, CAUSING A SMALL SCRATCH WITHOUT BLEEDING. THE TECHNICIAN RECEIVED FIRST AID AT THE COMPANY INFIRMARY. THE LABORATORY CONFIRMED THAT NO FURTHER MEDICAL ASSISTANCE WERE NEEDED. AS A PRECAUTIONARY MEASURE, THE TECHNICIAN IS UNDERGOING TRIPLE THERAPY TO PREVENT ANY POTENTIAL RISK OF HIV, ALONG WITH REGULAR BLOOD TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702077 FREEDOM EVOLYZER 2 150 STATION, PIPETTING AND DILUTING, FOR CLINICAL USE, PRODUCT JQW TECAN SCHWEIZ AG 30025238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown