MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK MS INSTRUMENT®; VITEK® MS INSTRUMENT

Catalog Number	410895
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced high blood glucose event on (b)(6) 2026 and got treated with pump.
Additional Manufacturer Narrative
Context: a customer in spain reported to biomérieux misidentification of staphylococcus spp as listeria monocytogenes leading to patient lumbar puncture (invasive testing) in association with the product vitek ms instrument (ref.410895, serial number (b)(6), ivd mode, kb version 3.3 (cli)).Vitek ms results: after 3 hours of incubation : four no identification and one single choice to listeria monocytogenes ¿ off label usage.After 24 hours of incubation : one low discrimination to staphylococcus pettenkoferi - staphylococcus capitis.After 72 hours of incubation : two single choices to staphylococcus pettenkoferi.Other method: gram staining = only able to see some staphylococcus-like morphologies.Bcid2 panel from the blood = positive for staphylococcus spp.Expected identification: staphylococcus pettenkoferi, however, no genomic reference testing performed.Culture conditions: culture media: chocolate plate.Incubation: cultured an agar plate dropping one drop of blood in the center and letting it incubate at 42ºc and c02 for at least 3h and a second plate with a normal smear.Spotting tool: unknown.Investigation: history record and trend analysis.There is no cause investigation nor capa associated with the customer's complaint.A check has been done for the last 12 months period with the error code vd misidentification - f871 and there was no trend identified.Investigation results: based on complaint description, customer used a short incubation method which is not validated and there are no performances claimed against it.In this case, the expected identification was obtained after the recommended incubation time written in the user manual - 161150-1304-f - vitek ms.In this kind of protocol, as it is very short incubation time, the proteins of the bacteria are not fully expressed and leads to non optimal spectra (i.E.Specifics peaks could be absent or with low intensity).And ¿polymicrobial specimen¿ (mixed organisms) cannot be detected with such method, because the culture is thin and colonies are not separated on plate, it is not possible to verify if the culture is pure (i.E.Impossible to check if only one organism).Then, it could generate identification issues.The analysis of the customer spectra will not be efficient because they were not obtained with the recommended incubation time.Cause of the identification issue was due to a too short incubation time, ¿off label use¿.Root cause analysis: operator error (off label use).Conclusion: the misidentification of staphylococcus spp as listeria monocytogenes leading to patient lumbar puncture (invasive testing) was due to an operator error / off label use.Recommendations were provided to biomérieux customer service for the customer: to remind workflows and protocols validated and described in vitek ms user manuals.To explain the risk to customer for using such off label method.There is no performance reconsideration associated with the product vitek ms (reference 410895).

• Brand Name: VITEK MS INSTRUMENT®
• Common Device Name: VITEK® MS INSTRUMENT
• Manufacturer (Section D): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMÉRIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: céline strauel ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 25092481
• Report Number: 9615754-2026-00001
• Device Sequence Number: 10018431
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K181412
• 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): 05/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 410895
• 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: 04/20/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown