MAUDE Adverse Event Report: BIOMERIEUX, S.A. VITEK® MS

Catalog 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 reported to biomerieux a mis-identification event when using the viteks instrument.The customer stated that he obtained an identification of raoultella planticola for a patient sample identified by a confirmatory method as klebsiella oxytoca.When specifically requested, the customer indicated no adverse patient impact occurred as a result of this event.An investigation will be initiated by biomerieux to investigate this event.

Manufacturer Narrative

This report was initially submitted due to a customer in the united states reporting the occurrence of misidentification of klebsiella oxytoca as raoultella ornithinolytica in association with the vitek® ms system.Biomérieux internal investigation was conducted using the isolate submitted by the customer.Investigational testing included: api® 50 che: low discrimination between raoultella planticola and klebsiella oxytoca.(b)(4): low discrimination between raoultella planticola and klebsiella oxytoca.The 16s sequencing: identification to raoultella ornithinolytica.This investigation concluded the vitek® ms provided the correct result and is performing as intended.

• Brand Name: VITEK® MS
• Type of Device: VITEK® MS
• Manufacturer (Section D): BIOMERIEUX, S.A.; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 5894346
• MDR Text Key: 52741012
• Report Number: 3002769706-2016-00151
• Device Sequence Number: 1
• Product Code: PEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• 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
• Date Manufacturer Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1