MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK MS AQUISITION STATION

Model Number 4700394

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) notified biomerieux of a misidentification of cruoricaptor ignavus as a (b)(6) in association with the vitek ms instrument using the direct spotting method.The isolate was from an aerobic blood culture, that was gram negative coccobacilli.The customer reported that chocolate agar and macconkey agar culture showed no bacterial growth at 48 hours, while blood agar was showing no growth at 24 hours and small colonies at 48 hours.After attempting to identify the isolate via bruker maldi-tof and obtaining a non reliable id; the customer sent the strain out to a (b)(6) lab for next generation sequencing.The lab identified the strain as cruoricaptor ignavus.This was the result 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 biomerieux investigation has been initiated.

Manufacturer Narrative

An internal investigation was performed for a misidentification of cruoricaptor ignavus as a brucella species (99.9%) in association with the vitek® ms instrument using the direct spotting method.Biomérieux analyzed the data provided from the tests performed.*conclusion on the system the spot preparation quality is not optimal.The calibrator and sample "all peaks" values are heterogeneous.This could be explained by a non-optimal spot preparation of the calibrator strain (culture, spot, different operator).Because of this spot preparation issue, it is not possible to assess the system status in january (need of fine tuning) for the instrument s/n 51108.However, a new fine tuning was done just before the new tests done in april 2019, so the system was operational at that period.*conclusion on the identification: with the information provided by the local customer service, the identification is cruoricaptor ignavus (confirmed by sequencing).Cruoricaptor ignavus is not present in the vitek ms kb v3.2.The strain was tested several times and the expected identification "no identification" was obtained most of the time (51 times out of 55 tests).To explain the 5 misidentifications that have been obtained, the following system limitation is mentioned in the vitek ms knowledge base user manual ref.161150-924a for vitek ms clinical use v3.2: "* testing of species not found in the database may result in an unidentified result or a misidentification.* interpretation of results and use of the vitek ms system require a competent laboratorian who should judiciously make use of experience, specimen information, and other pertinent procedures before reporting the identification of test organisms.Additional information known to the user, such as gram stain reaction, colonial and cellular morphology, and growth aerobically or in co2 should be considered when accepting vitek ms results." *suspected causes: - system limitation because cruoricaptor ignavus is not included in the knowledge base v3.2.-non optimal spot preparation.

• Brand Name: VITEK MS AQUISITION STATION
• Type of Device: VITEK MS AQUISITION STATION
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, les grottes isere 38390 ; FR 38390
• MDR Report Key: 8488037
• MDR Text Key: 148623783
• Report Number: 9615754-2019-00021
• 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: 06/15/2019

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: 4700394
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: 05/23/2019
• Supplement Dates FDA Received: 06/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1