MAUDE Adverse Event Report: BIOMERIEUX SA VITEK® MS

Model Number 410895

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported a misidentification of brucella spp as pseudomonas oryzihabitans in association with the vitek® ms instrument.The customer isolated a gram negative rod from blood culture and the vitek ms identified the isolate as pseudomonas oryzihabitans.The clinical symptoms and the anamnesis of the patient , indicated that it could be a brucella spp.The customer then performed pcr and sequencing which confirmed that it was brucella spp.The sample was also sent to a brucella reference laboratory for testing.The customer stated that the vitek ms result was not reported to the physician, and patient treatment was not impacted.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: conclusion on the system: it is not possible to assess the system status during the test (12 july 2018) because no mzml have been provided.The previous fine tuning completed on 6 june 2018 before the issue was not conform.All the peaks were under the target criteria.The fine tuning completed after the misidentification was confirmed.However, the linear detector value is above the limit (3210 instead of 3200 as it is mentioned in the service manual).The linear detector has been changed based on the system historical data.Conclusion on the identification: based on the complaint description, the expected identification is brucella melitensis.The customer has confirmed the identification by a molecular method.Brucella melitensis is not present in the vitek® ms knowledge base (kb) v3.0 used by the customer.There is a system limitation mentioned in the vitek ms v3.0 knowledge base clinical use 161150-556 - b : "testing of species not found in the database may result in an unidentified result or a misidentification".For information, next vitek ms kb 3.2 is including brucella melitensis, it will be displayed as brucella spp (genus identification only).As no sample data was provided for investigation it was not possible to confirm if this identification could be obtained by reprocessing with next kb v3.2.Suspected cause of the issue: system limitation (species not in the kb 3.0).Non optimal fine tuning.

• Brand Name: VITEK® MS
• Type of Device: VITEK® MS
• Manufacturer (Section D): BIOMERIEUX SA; 3 route de port michaud; la balme les grottes isere 383, ; FR
• MDR Report Key: 7819397
• MDR Text Key: 118757724
• Report Number: 3002769706-2018-00170
• Device Sequence Number: 1
• Product Code: PEX
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• PMA/PMN Number: DEN130013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

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: Health Professional
• Device Model Number: 410895
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2018
• Initial Date FDA Received: 08/27/2018
• Supplement Dates Manufacturer Received: 09/07/2018
• Supplement Dates FDA Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1