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 of trichophyton mentagrophytes (atcc1) sample as trichophyton interdigitale in association with the vitek® ms instrument.The molds protocol was followed strictly and the customer used the vitek ms molds kit.It is not known if another identification method was used.The customer stated results for other samples were no identification.The customer stated that no incorrect result was reported to a physician, and patient results and treatment were not impacted.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer reported a misidentification of trichophyton mentagrophytes (atcc1) sample as trichophyton interdigitale in association with the vitek® ms instrument.An investigation was performed.The data provided from the customer's test was analyzed.Investigation findings: the system was operational during the tests.Based on the analysis of the results obtained from calibration spots, the sample preparation was quite heterogeneous.However, there is a minor effect for mold identification protocols as liquid is added on the spot at the end of the protocol.Results interpretation: the information provided regarding the sample id atcc1 allowed us to conclude that the most probable identification is trichophyton mentagrophytes.There is a specific limitation in the vitek ms v3.0 knowledge base clinical use - 161150-556 - b - (page 1-5) regarding trichophyton: "there is a possibility of cross-identification between the following vitek ms displayed taxa: displayed taxon: trichophyton mentagrophytes.Possibility of associated displayed taxon: trichophyton interdigitale" probable root cause: system limitation with the possibility of cross-identification between trichophyton mentagrophytes and trichophyton interdigitale.

• 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: 7138923
• MDR Text Key: 95803466
• Report Number: 3002769706-2017-00408
• 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: 02/23/2018

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: 11/24/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 01/31/2018
• Supplement Dates FDA Received: 02/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1