BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITEK 2 0.45% SODIUM CHLORIDE DILUENT

    MDR report key: 24326644 · Received February 12, 2026

    Report

    Report Number
    1950204-2026-00001
    Event Type
    Injury
    Date Received
    February 12, 2026
    Report Date
    February 12, 2026
    Manufacturer
    BIOMÉRIEUX INC.
    Product Code
    LON
    UDI-DI
    03573026463533
    PMA / PMN Number
    N50510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INTENDED USE: SALINE SOLUTION IS A DILUENT USED FOR MANUAL PREPARATION OF ORGANISM SUSPENSIONS, PRIOR TO IDENTIFICATION AND ANTIMICROBIAL SUSCEPTIBILITY PROCESSING WITH VITEK® 2 INSTRUMENTS. THE VITEK 2 0.45% SODIUM CHLORIDE DILUENT - 417820 IS NOT MANUFACTURED BY BIOMÉRIEUX. THIS ITEM IS A THIRD-PARTY PRODUCT MANUFACTURED BY PISA. ISSUE DESCRIPTION: A CUSTOMER IN AUSTRIA NOTIFIED BIOMÉRIEUX OF USER HARM RELATED TO VITEK 2 0.45% SODIUM CHLORIDE DILUENT (REF. 417820, LOT Q2410028 , EXP DATE 01-APRIL-2026). USER WAS INJURED WHILE MODIFYING A NEW VITEK 2 0.45% SODIUM CHLORIDE DILUENT TO BE PLACED IN THE VITEK 2 XL AS THE MOUNTING HOLE WAS TOO SMALL TO FIT ONTO THE MOUNTING PIN IN SIDE THE INSTRUMENT. THE USER ATTEMPTED TO ENLARGE THE HOLE WITH SCISSORS. DURING THIS SCISSORS USE, USER WAS INJURED; SHE OBTAINED A FINGER LACERATION WHICH NEEDED TO BE SUTURED AND UNDERWENT TREATMENT. USER IS UNABLE TO WORK FOR THREE WEEKS. NOTE: THE PRODUCT, VITEK 2 0.45% SODIUM CHLORIDE DILUENT - 417820, DID NOT DIRECTLY CAUSE THE INJURY. THE USE OF SCISSORS BY THE CUSTOMER TO MODIFY THE SALINE BAG WAS THE CAUSE OF THE INJURY. CUSTOMER ALSO INDICATED THAT THE USER MANUAL STATES THAT THE SALINE BAG HOLE NEEDS TO BE PLACED ON THE PIN INSIDE THE INSTRUMENT TO PLACE THE BAG CORRECTLY. AS THIS WAS NOT POSSIBLE WITHOUT EXCESS FORCE AND MANIPULATION, CUSTOMER USED THE SCISSORS TO ENLARGE THE HOLE TO BE ABLE TO PUT THE BAG HOLE ON THE PIN. BIOMÉRIEUX GLOBAL INDUSTRY CUSTOMER SERVICE STATED THAT AS THERE IS NO MENTION IN ANY OF BIOMÉRIEUX OFFICIAL DOCUMENTATION TO USE SCISSORS, AND AFTER ANALYSIS OF VIDEO PROVIDED BY THE CUSTOMER, THE USER SHOULD HAVE REQUESTED HELP RATHER THAN USING SCISSORS TO INSTALL THE BAG. THE USE OF SCISSORS IS CONSIDERED TO BE OFF-LABEL USE AND USER ERROR. IN ALIGNMENT WITH BIOMÉRIEUX (B)(4), BIOMÉRIEUX VIGILANCE OPERATIONAL TEAM (VOT) REQUESTED THE BIOMÉRIEUX THIRD PARTY PRODUCTS (TPP) TEAM TO NOTIFY PISA OF THIS ISSUE DUE TO THE CLAIM OF AN INJURY. NOTE: PISA IS A CMO (CONTRACT MANUFACTURING ORGANIZATION) FOR THE SALINE BAG, AND THE BAG IS ACQUIRED BY PISA THROUGH A SUPPLIER (PYMPSA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385487 VITEK 2 0.45% SODIUM CHLORIDE DILUENT VITEK 2 0.45% SODIUM CHLORIDE DILUENT LON BIOMÉRIEUX INC. Q2410028 03573026463533

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention