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

Model Number 410895

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A biomérieux internal investigation was completed in response to this customer complaint.A complaint review was performed and did not identify any similar complaints related to the misidentification of vibrio parahaemolyticus as vibrio alginolyticus.The customer's raw data was reviewed for this investigation.Fine tuning: according to the vilink alert tool criteria, a fine tuning was needed during the tests made on (b)(6) 2020.However, the fine tuning indicators acceptance criteria could be affected by the quality of the spot preparation and by the calibrator culture, it might not reflect the real status of the system.It was confirmed by analyzing the ¿all peaks number¿ from calibrator strain during the period of the tests.Spot preparation quality: the customer¿s spot preparation quality was not optimal.The calibrator and sample ¿all peaks¿ values are quite heterogeneous.Knowledge base (kb) review: the expected identification is vibrio parahaemolyticus which is present in the vitek ms knowledge base (b)(4).Sample data analysis: the analysis of the mzml samples files shows that number of all peaks were heterogeneous (between 37 and 112).The misidentification is obtained from the spectra having the lowest number of peaks (37) which is near the acceptable limit (30) for giving an ¿identification¿ result or a ¿no identification¿ result.This could be explained by a non-optimal spot preparation of the sample strain.Root cause: from the data gathered during the investigation, the most likely root cause was determined to be non-optimal spot preparation.Local customer service (lcs) has been requested to provide the customer with additional training materials to improve spot preparation technique.

Event Description

A customer in (b)(6) notified biomérieux of obtaining a misidentification of vibrio parahaemolyticus as vibrio aliginolyticus while testing an (b)(6) proficiency sample with the vitek® ms (ref 410895, serial (b)(4)).Repeat analysis with the vitek® ms obtained the expected identification of vibrio parahaemolyticus.Initial vitek® ms: vibrio aliginolyticus; repeat vitek® ms: vibrio parahaemolyticus; expected: vibrio parahaemolyticus.As this was a proficiency sample, there is no patient involved.

• Brand Name: VITEK MS
• Type of Device: VITEK® MS
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 11033016
• MDR Text Key: 241369396
• Report Number: 9615754-2020-00193
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K181412
• 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: 12/17/2020

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
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 12/17/2020
• 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