BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESSORY KIT VTK2 PIP/DIL®

    MDR report key: 23553420 · Received November 14, 2025

    Report

    Report Number
    1950204-2025-00008
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Report Date
    December 31, 2025
    Manufacturer
    BIOMÉRIEUX INC.
    Product Code
    LON
    UDI-DI
    03573026049782
    PMA / PMN Number
    N50510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTEXT: A CUSTOMER IN FRANCE NOTIFIED BIOMERIEUX OF DAMAGE AND DEFECT OBSERVED ON ACCESSORY KIT VTK2 PIP/DIL (REF. 21219, LOT 1011213650, EXP DATE 05-MARCH-2027. TREND REVIEW: 04DEC2025 GCS REVIEWED THE VITEK 2 AND V2 COMPACT REAGENTS (BV2, BVC & BZC) COMPLAINT ERROR CODE TRENDING FOR Q2 2025 ¿ACCESSORY - DAMAGED/DEFECT - J002¿ (DEFINITION: NON-CARD VITEK 2 DISPOSABLE ITEM WITH DAMAGE, DEFECT, MISSING COMPONENT OR PERFORMANCE FAILURE.) ERROR CODE J002 WAS FOUND IN THE IMPACT LEVEL 2 CODES ¿ TOP 10. HISTORIC: PREVIOUS COMPLAINTS WERE RESOLVED BY REPLACING THE DISPENSERS, PIPETTES, AND SCRATCHED TUBES.Q2 2025: A SAMPLING OF COMPLAINTS FROM Q2 2025 WAS REVIEWED. COMPLAINTS WERE RESOLVED BY REPLACING PIP/DIL KITS, BROKEN OR SCRATCHED TUBES, AND THE SMALL DISPENSER. OTHERS WERE CORRECTED BY REPLACING THE MCFARLAND STANDARDS, SALINE OR THE DISPENSETTE. THE PIP/DIL KITS (21219) REPRESENTED 45% OF THE OVERALL COMPLAINTS. THE ISSUE IS BEING ADDRESSED UNDER INV-24018. NO OUT-OF-CONTROL POINT HIGH, 5 INCREASING CONSECUTIVE POINTS, NOR 9 CONSECUTIVE POINTS ABOVE THE CONTROL LIMIT CENTER LINE DURING THIS QUARTER. NO ADDITIONAL INVESTIGATION/ACTIONS ARE REQUIRED AT THIS TIME. INVESTIGATION RESULTS: ON 14NOV2024, LEVEL 1 CUSTOMER SUPPORT IN THE NETHERLANDS REPORTED, THAT FOR 2 OF THE 4 KITS THAT THE CUSTOMER RECEIVED FROM LOT 1010482950 HAD A BROKEN SHOT TUBE FOR PIP/DIL ACCESSORY KIT (REFERENCE 21219). PREVIOUS INVESTIGATION (B)(4) IDENTIFIED THE TWO MOST LIKELY ROOT CAUSES TO BE CHEMICAL MAKEUP OF THE PLASTICIZER OR THE DESIGN OF THE WALL SECTION OF THE SHOT TUBE. DUE TO THE INCREASING NUMBER OF COMPLAINTS AFTER THE CLOSURE OF (B)(4), A DECISION WAS MADE TO ADDRESS THE ROOT CAUSE BY PERFORMING A MATERIAL CHANGE FOR THE SHOT TUBE. INTERNAL TESTING SUCH AS MECHANICAL, FUNCTIONAL, AND MICRO-BIOLOGICAL TESTS WERE PERFORMED TO DETERMINE AN APPROPRIATE MATERIAL. INTERNAL TESTING IDENTIFIED A NEW MATERIAL THAT HAS BEEN VALIDATED. MANUFACTURING WITH THE NEW MATERIAL STARTED ON 08NOV2025. THE ROOT CAUSE WAS DETERMINED TO BE THE CHEMICAL MAKEUP OF THE PLASTICIZER WHICH IS A CHEMICAL USED IN THE ASSEMBLY OF THE PIP/DIL ACCESSORY KIT WHICH INCLUDES THE SHOT TUBE. CORRECTIVE ACTION: MATERIAL CHANGE FOR THE SHOT TUBE HAS BEEN IMPLEMENTED INTO THE MANUFACTURING PROCESS PER A CHANGE REQUEST. A CAPA WAS CREATED TO CAPTURE CORRECTIVE ACTIONS AND EFFECTIVENESS OF THE ACTIONS. A CSN (CUSTOMER SERVICE NOTIFICATION) WILL BE PUBLISHED TO PROVIDE THE DETAILS OF THE CHANGES FOR THE FIELD.

    Description of Event or Problem · 0

    INTENDED USE: VITEK 2 PIPETTOR / DILUTER ACCESSORY KIT CONTAINING PIPETTES FOR VITEK 2 AND VITEK 2 XL NEEDED TO PREPARE SAMPLE SUSPENSIONS. ISSUE DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMERIEUX OF DAMAGE AND DEFECT OBSERVED ON ACCESSORY KIT VTK2 PIP/DIL (REF. 21219, LOT 1011213650, EXP DATE 05-MARCH-2027. THE PIPETTOR/DILUTER KIT IS SEPARATED WHERE THE FLEXIBLE TUBING MEETS THE SHOT-TUBE FITTING. THE FITTING IS BROKEN OFF. THIS CAUSES INABILITY TO DISPENSE SALINE INTO THE AST SPECIMEN TUBES. WITHOUT THE PIPETTOR/DILUTOR ASSEMBLY, THE INSTRUMENT CANNOT PROCESS NEW SAMPLES. THE CUSTOMER STATED THAT ADDITIONAL NEW PIP/DIL ASSEMBLIES IN THE SHIPPING CONTAINER ARE ALREADY BROKEN AS WELL. AT THE TIME OF THE ASSESSMENT, THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1922889 ACCESSORY KIT VTK2 PIP/DIL® ACCESSORY KIT VTK2 PIP/DIL ® LON BIOMÉRIEUX INC. 1011213650 03573026049782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown