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 the united states notified biomérieux of misidentification results for two gram-negative strains when testing with the vitek® ms instrument (ref 410895).The vitek® ms identified gram-positive species.Sample 1: date: (b)(6) 2018.Vitek ms id: abiotrophia defectiva 99.7%.Expected id : gram negative as the strain grew on macconkey media (selective media).Sample 2: date: (b)(6) 2018.Vitek ms id: streptococcus constellatus 52.3%/bacillus licheniformis 47.6% alternate id: proteus mirabilis via vitek 2 testing, gram-negative rod via gram stain.Expected id: gram negative as the strain grew on macconkey media (selective media).The customer reported that the incorrect results were not reported to the physician.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.An internal biomérieux investigation has been initiated.

Manufacturer Narrative

An internal investigation was performed for the misidentification of two gram-negative strains when testing with the vitek® ms instrument (ref: 410895).*isolate 1 : mb18048914.Vitek ms results: no identification on the 5th of september.Single choice to abiotrophia defectiva on the 6th of september.Isolate 2 mb18049119.Vitek ms results: low discrimination results to streptococcus constellatus 52.3%/bacillus licheniformis 47.6% on the 5th september.Vitek 2: proteus mirabilis.Data provided from the tests was analyzed: investigation findings: the system was not operational during tests performed.A new fine tuning was done after the misidentification and the system is now operational.The sample preparation was non-optimal (the "all peaks number" from the calibrator strain is quite heterogeneous and it can be extrapolated to the sample).Results interpretation: regarding the complaint description, the vitek ms identifications are incorrect because proposed species are gram positive whereas species are supposed to be gram negative.To confirm the identification, molecular method has to be performed (it is considered as the reference method).Probable cause of the issue : non optimal fine tuning, spot preparation issue.

• Brand Name: VITEK® MS
• 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: 7938268
• MDR Text Key: 125138289
• Report Number: 3002769706-2018-00196
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• 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: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1