BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHO VISION ANALYZER GEL

    MDR report key: 20075178 · Received August 27, 2024

    Report

    Report Number
    2250051-2024-00033
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    July 24, 2024
    Report Date
    August 9, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSZ
    UDI-DI
    10758750012817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION DETAILS: IT WAS CONFIRMED THAT THE OPERATOR DID NOT WEAR PROTECTIVE GLASSES WHILE REMOVING THE BLOCKED CASSETTE. GTSC ANALYZED THE LOGFILES TO IDENTIFY WHICH CASSETTE WAS STUCK IN THE GRIPPER FINGER AND WHAT SAMPLE/REAGENT WERE DISPENSED AND FOUND ORTHO BIOVUE REVERSE DILUENT CASSETTE; LOT RDC123F; EXPIRY DATE 10 APRIL 2025; CASSETTE ID (B)(4). (ENCRYPTED SAMPLE ID DB-18-F3-CD-BC-31-7A-0A-0D-01-67-04-EF-38-A2-A0-21-E7-2B-0B-C6-1F-2BB3-8B-23-19-75-BF-2A-67-43) WITH 0.8% AFFIRMAGEN LOT 84A414. THE CUSTOMER STATED THAT THE SAMPLE IDENTIFIED HAS NOT YET BEEN TESTED FOR INFECTIOUS DISEASES. THE ASSIGNABLE CAUSE OF THE SPLASH IN OPERATOR'S EYE IS RELATED TO A USE ERROR, THE OPERATOR NOT FOLLOWING ORTHO RECOMMENDATIONS. GTSC WAS ASKED TO REMIND CUSTOMER TO WEAR LABORATORY PERSONAL PROTECTIVE EQUIPMENT WHILE PERFORMING TROUBLESHOOTING ACTIONS SUCH AS REMOVING A DISPENSED CASSETTE FROM THE GRIPPER FINGERS USING THE BLUE WHEEL. A MEDICAL CONSULTATION WAS REQUESTED PER WKI53814 AND IS COMPLETED. BASED ON THE COMPLAINT INFORMATION, THIS OPERATOR MAY HAVE BEEN EXPOSED TO THE CONTENT OF THE ORTHO BIOVUE DILUENT CASSETTE, ONBOARD SAMPLE, AND 0.8% AFFIRMAGEN. PER THE SAFETY DATA SHEET (SDS), THESE REAGENTS CONTAIN ANIMAL BLOOD DERIVATIVES, HUMAN BLOOD AND BLOOD PRODUCTS, AND MIXTURES SUCH AS 1-IMIDAZOLE, HYDROCHLORIC ACID, AND SODIUM AZIDE. DUE TO THE PRESENCE OF ANIMAL AND HUMAN BLOOD DERIVATIVES, THERE IS A RISK OF TRANSMISSION OF BLOOD-BORNE PATHOGENS UPON EXPOSURE TO THE BODY MUCOSA. DONORS AND DONATION BLOOD FOR ORTHO REAGENTS TESTED NEGATIVE PER CURRENT FDA-REQUIRED TESTS; THEREFORE, THE CHANCE OF BEING TRANSMITTED WITH THE COMMON BLOODBORNE PATHOGENS IS LOW. HOWEVER, NO TEST CAN GUARANTEE 100% DETECTION. SO, FOR PRECAUTION, THIS CASE IS CLASSIFIED AS SERIOUS INJURY. THE OTHER MIXTURES MAY CAUSE MILD ALLERGIC REACTIONS, BUT NO SERIOUS OR CHRONIC SEQUELAE ARE ANTICIPATED. NO OTHER POTENTIAL HAZARD IS ANTICIPATED BASED ON THE ROUTE AND QUANTITY OF EXPOSURE. NO FURTHER COMPLAINT HAS BEEN RECEIVED FROM THE CUSTOMER SITE SINCE THE TIME OF THE REPORTED EVENT.

    Description of Event or Problem · 0

    (B)(4), WINDCHILL (B)(4) A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON 30 JULY 2024 TO REPORT THAT WHILE MANUALLY REMOVING A DISPENSED CASSETTE FROM THE GRIPPER FINGERS, THE OPERATOR GOT SPLASH OF LIQUID CONTAINED IN THE CASSETTE IN ONE EYE. COMPLAINT REPORTER NAME AND POSITION: (B)(6), LABORATORY SUPERVISOR EVENT DATE: 30 JULY 2024 REAGENTS: ORTHO BIOVUE REVERSE DILUENT CASSETTE; LOT RDC123F; EXPIRY DATE 10 APRIL 2025 0.8% AFFIRMAGEN; LOT 84A414; EXPIRY DATE 06 AUGUST 2024 THE CUSTOMER REPORTED THAT DUE TO AN ERROR APSW000 (DETAIL GRIP1_8100) WHERE A DISPENSED CASSETTE GOT STUCK IN THE GRIPPER FINGERS, THE OPERATOR REMOVED THE CASSETTE MANUALLY BY PULLING HARDLY RATHER THAN USING THE BLUE WHEEL TO OPEN THE GRIPPER FINGERS AS RECOMMENDED AND GOT LIQUID FROM THE CASSETTE SPLASHED IN ONE EYE. THE CUSTOMER REPORTED THAT OPERATOR WAS TAKEN A BLOOD SAMPLE TO SCREEN VIRAL MARKERS AND OTHER LABORATORY EXAMS. NO FURTHER DETAILS WILL BE PROVIDED DUE TO PRIVACY CONCERNS. THE CUSTOMER REPORTED THAT THE OPERATOR WENT TO THE HOSPITAL AND GOT PRESCRIBED A SICKNESS LEAVE OF FIVE DAYS. THE CURRENT HEALTH STATE OF THE OPERATOR IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952178 ORTHO VISION ANALYZER GEL AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750012817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown