MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK® MS

Model Number 410895

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from the united kingdom reported to biomérieux a misidentification in association with the vitek® ms instrument.The customer reported that the vitek® ms result was streptococcus dysgalactiae, and the alternative method (pro-lab streptococcal grouping kit) result was group a streptococcus.The expected identification was unknown.The customer stated an incorrect result of streptococcus dysgalactiae was reported to the physician and the patient treatment was not impacted.There was a delay in reporting results.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

A customer from the (b)(6) reported a misidentification with a vitek® ms result of streptococcus dysgalactiae, and the alternative method result was group a streptococcus.The expected identification was unknown.An investigation was performed.Analysis of the instrument files confirmed the vitek ms system was operational during the customer test.Regarding the customer data, the most probable identification is streptococcus dysgalactie subspecies equisimilis.This identification was confirmed by a reference laboratory as streptococcus dysgalactie subspecies equisimilis - atypically lancefield group a.The data files provided by the customer were reprocessed with vitek ms kb v3.0 (clinical) and vitek ms kb v3.1 (for industry) and all spots gave low discrimination between str.Dys.Dysgalactiae and str.Dys.Equisimilis.The vitek ms worked as intended.There are the following limitations in the knowledge base user manual ref.161150-556-b for vitek ms clinical use v3.0: for str.Dys.Dysgalactiae and str.Dys.Equisimilis: subspecies or species group is displayed as a low discrimination result.A choice should be made between the proposed subspecies or species.Additional laboratory tests as determined by microbiology laboratory protocols for low discrimination results are necessary for the completion of the organism identification.The investigation concluded there was no issue with vitek ms.The identification of the strain was confirmed by reference laboratory as streptococcus dysgalactie subspecies equisimilis (atypically lancefield group a).The vitek ms worked as intended.

• 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: 7045833
• MDR Text Key: 93458362
• Report Number: 3002769706-2017-00376
• Device Sequence Number: 1
• Product Code: PEX
• 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: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410895
• Other Device ID Number: 03573026359119
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1