MAUDE Adverse Event Report: BIOMÉRIEUX INC. ACCESSORY KIT VTK2 PIP/DIL®; ACCESSORY KIT VTK2 PIP/DIL ®

Catalog Number	21219
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: ACCESSORY KIT VTK2 PIP/DIL®
• Common Device Name: ACCESSORY KIT VTK2 PIP/DIL ®
• Manufacturer (Section D): BIOMÉRIEUX INC.; 595 anglum rd.; hazelwood MO 63042
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum rd.; hazelwood MO 63042
• Manufacturer Contact: céline lacroix-gimon ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 23553420
• Report Number: 1950204-2025-00008
• Device Sequence Number: 13191393
• Product Code: LON
• UDI-Device Identifier: 03573026049782
• UDI-Public: 03573026049782
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: N50510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 21219
• Device Lot Number: 1011213650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/31/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown