MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK MASS SPECTROMETER; VITEK® MS¿

Model Number 410895

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of a misidentification in association with vitek® ms instrument (reference (b)(4)).A patient isolate was identified as single choice burkholderia multivorans with vitek® ms.They repeated isolate testing using vitek® 2 and obtained an identification of burkholderia pseudomallei.There was no further testing done to confirm the identity of the isolate.The treating physician focused on the vitek® 2 results in consideration with other parameters such as gram staining and morphology.The customer stated that there were no patient results affected and no wrong results reported to a physician.Per the customer, there was no delay in reporting patient results, no incorrect treatment given, and no harm to the patient.Analysis was performed on data submitted by the customer from their vitek® ms instrument.It concluded that the system was operational during the test.A final identification could not be confirmed with the information provided.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer had notified biomerieux of a suspected misidentification between burkholderia pseudomallei as burkholderia multivorans with vitek® ms ivd kb v2.0.The vitek ms instrument provided a result of single choice to burkholderia multivorans (spot b2).Vitek 2 gn id card provided an identification result of burkholderia pseudomallei.A biomerieux internal investigation was performed.As burkholderia pseudomallei is a pathogenic organism, return of the strains cannot be done.Investigation was performed only with the customer data.After analyzing the data provided by the customer, the following conclusions were made: the system was operational (status good: no fine tuning needed) during customer tests - analysis made according to criteria written in the service manual (vilink alert tool - mar 3262).Analysis of the "all peaks number" evolution: the analysis of the graph indicates that "all peaks number" is quite homogeneous.Sample preparation seems to be good.After analyzing the data provided with the next knowledge bases (vitek ms kb v3.0 and v3.1), the most probable identification is burkholderia pseudomallei.B.Pseudomallei is not present in any of the vitek ms knowledge bases.The root cause of this identification issue is the system limitation, this specie is not present in any of the vitek ms knowledge bases.Vitek ms system identification is based on a species pattern classification.Organism species not present in the knowledge base can yield a result where no specific species pattern will be available in the database for comparison.Consequently, the system can provide: no identification (no-id - most probable answer) when the spectrum acquired doesn't match with any species pattern.An incorrect single choice identification to the nearest pattern species (often same genus) when the spectrum acquired presents high level of similarity with a specific species pattern present in the database.A low discrimination identification (often the same genus) when the spectrum acquired presents high level of similarity with multiple specific species patterns present in the database.

• Brand Name: VITEK MASS SPECTROMETER
• 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: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6937285
• MDR Text Key: 90295170
• Report Number: 3002769706-2017-00295
• Device Sequence Number: 1
• Product Code: PEX
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2018

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: 410895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2017
• Initial Date FDA Received: 10/10/2017
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 01/12/2018
• 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