MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK® MS

Model Number 410710

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Biomérieux analyzed the data provided from the tests performed.Conclusion on the system: the system was operational during the tests.The calibrator spot preparation quality seems to be good.The calibrator "all peaks" values are quite homogeneous.Conclusion on the identification: the expected identification is unknown because no reference method was performed to confirm the identification.The vitek ms gave "no identification" for three of the four tests made for this sample.The spectra leading to an identification to a.Baumannii complex had a lower number of peaks compared to the others.Based on this information, the strain is most likely not a.Baumannii complex.It could be a species that is not in the vitek ms database.In this case, sequencing should be made to confirm the real identification of the strain.Neither vitek ms kb v3.0 nor vitek ms kb v3.2 contain acinetobacter bereziniae (result gave by bruker).In this case, there is a system limitation mentioned in the vitek ms kb user manual (ref (b)(4)): "testing of species not found in the database may result in an unidentified result or a misidentification.Suspected cause of the issue: customer tested acinetobacter bereziniae which is not contained in the knowledge base.No reference method was performed by the customer to confirm the identification.

Event Description

A customer in (b)(6) reported a misidentification of acinetobacter bereziniae as acinetobacter baumannii complex in association with the vitek® ms instrument and axima assurance launchpad pc.The vitek ms identified acinetobacter baumannii complex (71%), and bruker mass spectrometry identified acinetobacter bereziniae.The expected identification was not known.The customer reported that no patient was harmed or had delayed treatment due to the misidentification.

• 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
• Manufacturer (Section G): BIOMERIEUX, SA; 3 route de port michaud; la balme, les grottes isere 38390 ; FR 38390
• Manufacturer Contact: debra broyles ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 8047034
• MDR Text Key: 128596280
• Report Number: 3002769706-2018-00233
• Device Sequence Number: 1
• Product Code: PEX
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2018

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 Model Number: 410710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 11/07/2018
• 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