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 corynebacterium pyruviciproducens as corynebacterium glucuronolyticum for a patient isolate (washed sperm sample) in association with the vitek® ms instrument.The vitek ms identified c.Glucuronolyticum, and the 16s sequencing result was c.Pyruviciproducens (98% with a 96% c.Glucuronolyticum).The result was initially reported as probable corynebacterium glucuronolyticum and then was sent for 16s sequencing for confirmation.The customer stated patient treatment was not impacted.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was initiated due to a customer report of a misidentification of corynebacterium pyruviciproducens as corynebacterium glucuronolyticum for a patient isolate (washed sperm sample) in association with the vitek® ms instrument.The vitek ms identified c.Glucuronolyticum, and the 16s sequencing result was c.Pyruviciproducens (98% with a 96% c.Glucuronolyticum).The customer data from the tests performed was provided and analyzed.Conclusion on the system: the system was not operating at system specifications during the tests: fine tuning was needed; the customer's calibrator spot preparation quality seemed to be good.The calibrator "all peaks" values are quite homogeneous during the tests.It could be extrapolated to the samples spots quality preparation.Conclusion on the identification: regarding the sequencing information, the expected identification is corynebacterium pyruviciproducens.It was confirmed by the analysis of the nucleotides sequence by r&d with smartgene (solutions to the management and analysis of genetic information, for clinical, medical research, veterinary, and industrial applications).The tested species is not included in the vitek ms knowledge base (kb) v3.0.The following system limitation is mentioned in the vitek ms knowledge base user manual ref.161150-556-b for vitek ms clinical use v3.0: "testing of species not found in the database may result in an unidentified result or a misidentification." it can be observed from the analysis of the 16s sequencing and the nucleotides sequence that both species, corynebacterium pyruviciproducens and corynebacterium glucuronolyticum, are very similar.This could explain the misidentification obtained.Suspected cause of the issue: system limitation, species not in the knowledge base v3.0.Note: the fine tuning was needed when the test was done; however, this is not retained as a cause of the issue because these two species are very close (98% for c.Pyruviciproducens and 96% for c.Glucuronolyticum based on sequencing report) and the expected organism is not present in the kb.Consequently, it is probable that this misidentification could occur with a properly fine-tuned system.

• Brand Name: VITEK® MS
• Type of Device: VITEK® MS
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, les grottes isere 38390 ; FR 38390
• MDR Report Key: 8170943
• MDR Text Key: 131409465
• Report Number: 3002769706-2018-00253
• 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: 01/15/2019

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: 11/17/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 12/18/2018
• Supplement Dates FDA Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1