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 (b)(6) reported to biomérieux a misidentification in association with the vitek® ms instrument.The customer reported the vitek® ms results for a sample were no identification and single choice to clostridium difficile.The sample was tested with the vitek® 2 which gave a result of leuconostoc mesen (94%).The expected identification was unknown, however, the customer stated they knew from direct culture plates that it was an enterococcus.The customer reported that an incorrect result was not reported to a physician and patient results and treatment were not impacted.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from (b)(6) had reported to biomérieux a misidentification in association with the vitek® ms instrument.Vitek ms result: * spot e1 : no identification * spot e2 : single choice to clostridium difficile.Other identification method: * vitek 2 = leuconostoc mesen * vre chrom and vitek gp card = enterococcus.A biomérieux internal investigation was performed using the data submitted by the customer.The strain was not submitted for further evaluation.Investigation conclusion: => conclusion on the system: system was operational during the test.=> conclusion on the identification: regarding the customer data, the most probable identification is enterococcus (based on vre chrom and vitek gp card).However, as no feedback was received about the results obtained after retest with a good quality spot preparation, it is not possible to conclude on the vitek ms results and define the root cause of the misidentification issue.To confirm the identification, the reference molecular method is sequencing.=> suspected root cause of the issue: the analysis of ecal mzml files indicates that "all peaks number" are not so homogeneous, which could be linked to the quality of the sample preparation.So the spot preparation has to be optimized.However, as no feedback has been received about the results obtained after retest with a good quality spot preparation, it is not possible to define the root cause of misidentification issue.

• 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: 6987723
• MDR Text Key: 91345013
• Report Number: 3002769706-2017-00323
• 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: 01/30/2018

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
• Other Device ID Number: 03573026359119
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2017
• Initial Date FDA Received: 10/30/2017
• Supplement Dates Manufacturer Received: 01/04/2018
• Supplement Dates FDA Received: 01/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1