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

On (b)(6) 2017, a customer in (b)(6) notified biomérieux of a misidentification in association with vitek® ms instrument (reference 410895).An isolate growing on blood agar anaerobically had been identified as nocardia paucivorans 99.9% with vitek® ms.However, this identification was not coherent with the culture.Another identification by mass spectrometry was done and gave a result of "no identification".Based on cultural characteristics and the gram staining, the customer reported the identification as bifidobacterium spp, which was not the vitek® ms's identification result.This was confirmed by discussion with experienced staff.The customer stated that the patient result was not affected, and the issue did not lead to patient harm or incorrect treatment.The customer stated there was a delay greater than 24 hours in reporting the result.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

A customer in (b)(6) reported a misidentification in association with the vitek® ms instrument (reference 410895).An investigation was performed.The instrument data provided was analyzed with vitek ms kb (b)(4) (for clinical use) and with vitek ms kb (b)(4) (for industry use).The results were: vitek ms kb (b)(4) (for clinical use): on (b)(6) 2017: 1 single choice to nocardia paucivorans and 1 no identification.On (b)(6) 2017: 2 no identifications.Vitek ms kb (b)(4) (for industry use): on (b)(6) 2017: 2 no identifications.On (b)(6) 2017: 2 no identifications.The discrepant results observed between vitek ms kb (b)(4) and vitek ms kb (b)(4), was due to improvements implemented since kb (b)(4), regarding the acceptance criteria to give an identification: the algorithm and the data base are different.In addition, the spot preparation quality was non-optimal during the test.The probable root cause of the identification issue could be linked to a system limitation (regarding bifidobacterium species).The expected identification could be a bifidobacterium species not present in any of the vitek ms knowledge bases.However, without the strain return, it is not possible to confirm.There are the following limitations in the kb user manual ref.161150-556-b for vitek ms clinical use (b)(4): "species group "bifidobacterium spp" is the final identification displayed in myla.The following subspecies or species included in the group are listed below: bifidobacterium adolescentis, bifidobacterium bifidum, bifidobacterium breve, bifidobacterium dentium, bifidobacterium longum." "testing of species not found in the database may result in an unidentified result or a misidentification." regarding "no identification" results, there is a specific comment in the vitek ms workflow user manual clinic use ref.4501-2233 - e explaining how to manage the "no identification" results: "[p150] sample spot: no identification: repeat the acquisition for the same deposit.If the message is displayed again, redo the deposit and then the acquisition.If the message is displayed again, repeat the identification using another method (such as vitek 2, api strip, other biochemical or molecular methods)." in this case, sequencing is the reference molecular method to identify the sample.

• 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
• Manufacturer (Section G): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6984439
• MDR Text Key: 91093427
• Report Number: 3002769706-2017-00321
• Device Sequence Number: 1
• Product Code: PEX
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: DEN130013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1