MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK MS INSTRUMENT - 410895; VITEK® MS INSTRUMENT - 410895

Model Number 410895

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported that he obtained a misidentification as prevotella oris (99.9%) when testing a sample with vitek® ms instrument (ref.410895) ¿ serial number (b)(4).Sample #: (b)(6).The customer performed a gram stain that reveals gram positive rods while prevotella oris is a gram negative.He also observed that the organism grew in both anaerobic and aerobic environment while prevotella oris should only grow in anaerobic environment.There is no patient involved as the customer is an industry customer.(b)(4) was created to investigate this report.

Manufacturer Narrative

An industry customer in canada notified biomérieux of obtaining the misidentification of gram positive organism as prevotella oris (gram negative) in association with their vitek® ms instrument (ref.410895; serial# (b)(6)).The strain was identified by arnr 16s sequencing as paenibacillus spp.Investigation.Investigator reviewed the complaint database for reports of organism misidentification due to a system limitation (species not in the kb).There is no capa, no non-conformity for vitek ms linked with customer 's complaint.Since (b)(6) 2016, two cases (different customers) were reported where paenibacillus etheri was misidentified as prevotella oris.The vitek ms r&d department has improvements in development related to the vitek ms database library by adding new species of paenibacillus etheri and updating of prevotella oris spectra contained in the database.For the reported issue, fine-tuning status was good at the time of acquisition.Spot preparation quality: the customer¿s spot preparation quality was not optimal.The calibrator and sample ¿all peaks¿ values were heterogeneous.Knowledge base (kb) review: per arnr sequencing, the strain was identified as a paenibacillus spp (p.Etheri, p.Odorifer, or p.Borealis).None of these are in the current vitek® ms knowledge base (v3.2).Sample data analysis: this misidentification was obtained with a low identification score (-0.39) which is near the acceptable limit for giving an identification result vs.A ¿no identification¿ result (-0.40).The following information is noted within the vitek® ms v3.2 knowledge base user manual (ref.161150-923-a): ¿testing of species not found in the database may result in an unidentified result or a misidentification.Interpretation of results and use of the vitek ms system require a competent laboratorian who should judiciously make use of experience, specimen information, and other pertinent procedures before reporting the identification of test organisms.Additional information known to the user, such as gram stain reaction, colonial and cellular morphology, and growth aerobically or in co2 should be considered when accepting vitek ms results.¿.Root cause was determined to be a system limitation where the species is not present in the vitek® ms v3.2 knowledge base.It was recommended that local customer service check sample preparation with the customer and provide customer training materials to improve their spot preparation technique, as well as reviewing with them mandatory criteria for fine-tuning.

• Brand Name: VITEK MS INSTRUMENT - 410895
• Type of Device: VITEK® MS INSTRUMENT - 410895
• Manufacturer (Section D): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 10980327
• MDR Text Key: 241367474
• Report Number: 9615754-2020-00188
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• PMA/PMN Number: K181412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

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
• Device Operator: Other
• Device Model Number: 410895
• Device Catalogue Number: 410895
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1