MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK MASS SPECTROMETER; 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) notified biomérieux of misidentification results for three strains tested with the vitek® ms instrument (reference 410895).Vitek® ms obtained the following results: sample id (b)(6): -spot j1: single choice to candida parapsilosis.-spot j2: low discrimination to candida dubliniensis - blastomyces dermatitidis - fusarium oxysporum complex.-spot j3: no identification.-vitek® 2 gave a low discrimination to candida famata - candida lipolytica - candida sake.Sample id (b)(6): single choice to arthroderma benhamiae.Expected identification per customer: trichophyton benhamiae.Sample id (b)(6) (on sabouraud agar, 20 days).-spot a2: single choice to epidermophyon floccosum.-spots a1, a3: no identification (not enough peaks).Final identification per customer = trichophyton violaceum.The customer stated that there were no patient results affected, no wrong results reported to a physician, and no delay in reporting patient results.The customer stated there was no incorrect treatment given or patient harm.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from israel notified biomérieux of misidentification results for three strains tested with the vitek® ms instrument (reference (b)(4).An investigation was performed.*conclusion on the system - the system was operational during the test (fine tuning acceptance criteria conformed).- there was a high heterogeneity observed for "all peaks" of the calibrant strain, so the spot preparation has to be checked with the user.It could explain the identification issue only for strain 1 (id (b)(6).For the other cases, the molds protocol has been used, as the user put a liquid on the spots, so there is no smearing step.*conclusion on the identification: - strain 1 (accession id (b)(6): discrepancy between vitek ms and vitek 2: no conclusion.The expected identification is unknown, low discrimination results were obtained on the other vitek 2 and no reference method (sequencing) was performed.- strain 2 (accession id (b)(6): the vitek ms gave the expected identification.There is no identification issue.With vitek ms kb v3.0, it is possible to identify the sexual (arthroderma benhamiae) and asexual (trichophyton mentagrophytes) form of trichophyton mentagrophytes, as described in the mycobank taxonomy, for molds taxonomy, there is no clear standard as it exist for bacteria.Biomerieux has decided to follow mycobank standard to build this database.The expected identification (provided by neqas) is trichophyton benhamiae which is the same as arthroderma benhamiae (sexual form).Trichophyton benhamiae is not present in mycobank taxonomy.- strain 3 (accession id (b)(6): discrepancy between expected id (trichophyon violaceum) and vitek ms id (e.Floccosum or "not enough peaks").Discrepancy could be due to an issue during the molds protocol steps (e.I.Too low quantity of material taken from the plate, age of the culture).Two spots out of the three gave "not enough peaks".After reprocessing the customer's data with kb v3.1 industry and future clinical kb in development, results were different for the spot that gave "e.Floccosum": - kb v3.1 industry: single choice to trichophyon violaceum - future clinical kb in development: low discrimination between e.Floccosum and trichophyon violaceum.There is no assurance about the expected identification, as it is not known if the customer did a reference method (molecular) to identify the sample to trichophyon violaceum.As no more information has been provided regarding the re-test, it is not possible to conclude on this sample.Final conclusions: - for strain 2 there is no identification issue.- for strain 1 and 3 it is not possible to conclude.The expected identification is unknown or not reliable due to lack of information.

• Brand Name: VITEK MASS SPECTROMETER
• 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: 7084359
• MDR Text Key: 95075706
• Report Number: 3002769706-2017-00396
• 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: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1