MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK® MS INSTRUMENT

Catalog Number 410895

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer reported to biomerieux a misidentification event occurred when using the viteks instrument.The customer reported that the vitek ms instrument returned a result of enterococcus cassilliflavus; however, the neqas proficiency sample should have been enterococcus gallinarum.Since this is a proficiency sample, there was no patient results involved in this event.An investigation has been initiated by biomerieux to investigate this event.

Manufacturer Narrative

A customer reported to biomerieux a misidentification event occurred when using the vitek® ms instrument.An internal biomérieux investigation was performed.Ivd mode - neqas specimen 3250 / distribution 3926 (external quality control) - expected id: enterococcus gallinarum, results obtained by the customer: vitek® 2 result : e.Gallinarum 98%.Api result: 50/50 e.Casseliflavus, e.Gallinarum.Vitek® ms result (labid: 16m4015606, run on 12 and 19jul2016): e.Casseliflavus (99.9% and identification obtained 3 times).Note: only two (2) sample mzml files were provided for investigation: one (1) gave e.Casseliflavus and the other noid.Each isolate was incubated on columbia blood agar (oxoid) for 18-24 hours in co2.One (1) passage was performed before the first run on the vitek® ms, and there were eight (8) passages before the second time the isolate was run.A fresh overnight culture of the organism was used each time.It was noted that the organism did not have a yellow pigment (note: e.Casseliflavus colony is yellow).Each time the isolate was run on the vitek® ms it was applied to the slide in duplicate, as per laboratory protocol.There was no need for re-aquisition or re-deposit as a good result was achieved first time and the e.Coli control passed the calibration both times.Investigation conclusion: the analysis of the data provided (ecal mzml) indicates that the system seems to be operational.Fine-tuning criteria are met.However, several spectra were too noisy, too many peaks, no identification.The sample preparation should be checked at the customer site.Biomérieux r&d department tested the neqas strain internally.The organism was subcultured on cba media, tested on vitek® ms, 16s sequencing, on vitek2, api20strep and rapidid32strep strips.Sequencing 16s: identification to enterococcus gallinarum 100%, so intended neqas result is confirmed.Vitek® ms gave a correct identification to enterococcus gallinarum 99.9% (5/5 spots).Therefore, the customer misidentification was not reproduced.Nevertheless, on vitek® 2 and api strips, we observed an atypical biochemical profile.The most probable root cause of the customer's misidentification is a spot preparation issue.This is the first complaint recorded for this issue (vitek ms e.Casseliflavus instead of e.Gallinarum).

• 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
• 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: 5987297
• MDR Text Key: 55990783
• Report Number: 3002769706-2016-00349
• Device Sequence Number: 1
• Product Code: PEX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K124067
• 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: 08/30/2016

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 Catalogue Number: 410895
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2016
• Initial Date FDA Received: 09/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1