MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK MS INSTRUMENT

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 in (b)(6) notified biomérieux of three misidentifications of candida tropicalis (c.Tropicalis) as candida albicans (c.Albicans) in association with the vitek® ms instrument.The identifications were confirmed as c.Tropicalis via vitek 2 and pcr.In addition, the customer confirmed that they are using knowledge base version 3.2 and were following best practices for use of the vitek ms instrument.The customer reported that there was no incorrect result reported, and no patient impact.An internal biomérieux investigation has been initiated.

Manufacturer Narrative

An internal biomérieux investigation was initiated due to a customer report of three misidentifications of candida tropicalis (c.Tropicalis) as candida albicans (c.Albicans) in association with the vitek® ms instrument using knowledge base (kb) version 3.2.The identifications were confirmed as c.Tropicalis via vitek 2 and pcr.All data submitted by the customer was reviewed as part of the investigation.*conclusion on the system: =>the customer's vitek ms system was at the limit for the test performed on (b)(6) 2019, and the system was not operational due to non-optimal fine-tuning at the time of testing on (b)(6) 2019.=>the customer's spot preparation quality seems to be good.The calibrator values are quite homogeneous.*conclusion on the identification: based on the complaint information the probable identification is candida tropicalis.This identification was confirmed by sequencing for at least one sample (lab id (b)(6).*suspected cause of the misidentification: non-optimal fine tuning.

• Brand Name: VITEK MS INSTRUMENT
• Type of Device: VITEK MS INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, les grottes isere 38390 ; FR 38390
• MDR Report Key: 8480543
• MDR Text Key: 147198908
• Report Number: 9615754-2019-00020
• 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: 05/06/2019

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: 03/06/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 04/12/2019
• Supplement Dates FDA Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1