MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK MS INSTRUMENT

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) notified biomérieux of the misidentification of turicella otitidis (origin: ear smear) in association with the vitek® ms system.Incubation time is 48h to 72h, and collection occurs as soon as colonies are present.Multiple vitek® ms acquisitions obtained organism identifications of staphylococcus epidermidis (4x), finegoldia magna (1x), peptoniphilius asaccharolyticus (1x) and "noid p150" (4x).Testing via vitek® 2 anc id test kit obtained the expected result of turicella otitidis.For this strain: gram stain: gram positive bacillus.Vitek ms analysis was performed from a colony isolated on the same plate used for vitek® 2 anc id test.The customer stated there was no delay in reporting and no adverse impact to the patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed for a customer report of misidentification of turicella otitidis in association with the vitek® ms instrument using knowledge base (kb) version 3.2.Biomérieux analyzed the data provided from the customer.*conclusion on the system: - the customer's system was operational during the tests.- the analysis of the sample tests indicates that there is a high variation of "all peaks values" (between 59 and 137), so there is an issue with the sample spot preparation.*conclusion on the identification: with the information provided, the most probable identification is turicella otitidis.The strain was not available therefore biomérieux was not able to confirm the identification.Biomérieux analyzed the provided data which showed heterogeneity of the fingerprint peak lists (masses list).However, all the results obtained had a high identification confidence level indicating the identifications were not inaccurate.It is also possible the staphylococcus epidermidis result was caused by a contamination due to sample preparation.The "no identification" results, could be explained by the presence of very high masses potentially due to the presence of culture media (columbia sheep blood) in the deposit.Turicella otitidis is a coryneform gram positive bacteria and the size of the colony is usually small (1 to 2 mm diameter).*suspected cause: -misuse : mixed culture (operator error) leading to obtain different identifications for the same culture plate.Vitek ms is not intended to be used on mixed-culture, as per vitek ms workflow user manual (reference (b)(4), paragraph "samples": "the microorganisms to be identified must first be isolated on a suitable culture medium." the results provided by vitek ms were not consistent with the gram straining of the strain: all vitek ms results were gram positive cocci and the strain was a gram positive bacillus.Consequently, the misidentifications could have been detected.The following limitations are written in the vitek ms kb user manual ref (b)(4): "-note: interpretation of results and use of the vitek® ms system require a competent laboratory technologist who should judiciously make use of experience, sample 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 in an aerobic or a co2 atmosphere, should be considered when accepting vitek® ms results.-review the context of your result to determine whether the vitek® ms identification is consistent with your environment.".

• Brand Name: VITEK MS INSTRUMENT
• Type of Device: VITEK MS INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, les grottes isere 38390 ; FR 38390
• MDR Report Key: 8524450
• MDR Text Key: 152100729
• Report Number: 9615754-2019-00022
• 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: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• 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: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1