MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK® MS

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) reported discrepant results in association with the vitek® ms instrument.The customer stated an isolate from a patient urine sample was first identified with the vitek ms as citrobacter koseri 99.9%, and then as citrobacter sedlakii 99.9% when repeated.The customer stated that reporting was delayed because of esbl (extended spectrum beta-lactamase) confirmation, and that there was no impact to patient treatment.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in canada reported discrepant results in association with the vitek® ms instrument.The customer stated an isolate from a patient urine sample was first identified with the vitek ms as citrobacter koseri 99.9%, and then as citrobacter sedlakii 99.9% when repeated.The expected identification is not known.An internal biomérieux investigation was opened.The customer was contacted multiple times in an effort to attain information to assist with an investigation.The customer did not provide any further information, nor was the strain submitted for investigation.Since the customer did not provide additional information or the strain for investigation, it was not possible to investigate this case to find the root cause of the issue.

• Brand Name: VITEK® MS
• Type of Device: VITEK® MS
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, 38390 ; FR 38390
• MDR Report Key: 8746795
• MDR Text Key: 151042265
• Report Number: 9615754-2019-00047
• 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: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2019
• 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
• Date Manufacturer Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1