MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK® MS; 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 inconsistent identification results while testing an isolate with the vitek® ms (ref 410895, serial (b)(4)).Testing of the same isolate three (3) times produced identifications of (b)(6) result of (b)(6).The isolate was submitted to a reference laboratory as a possible neisseria meningitidis strain and was tested via polymerase chain reaction (pcr).The reference laboratory results ruled out (b)(6)/ neisseria meningitidis.The customer reported that there was no adverse impact to any patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in australia regarding inconsistent identification results while testing an isolate with the vitek® ms (ref 410895, serial (b)(6)).Testing of the same isolate three (3) times produced identifications of neisseria gonorrhoeae, neisseria polysaccharea, and a slashline result of neisseria polysaccharea / neisseria lactamica.The isolate was submitted to a reference laboratory as a possible neisseria meningitidis strain and was tested via polymerase chain reaction (pcr).The reference laboratory results ruled out neisseria gonnorrhoea / neisseria meningitidis.An internal biomerieux investigation was performed.*conclusion on the fine tuning -fine tunings performed before the identifications issues were conformed.All mandatory acceptance criteria were achieved.-the analysis of the calibrator mzml files indicated that no fine tuning was needed during the tests made between 22 jul 2019 and 26 jul 2019.*conclusion on spot preparation quality: according to the data analyzed, the calibrator "all peaks" values are homogeneous.Spot preparation of the sample and calibrator strain seems to be good.*conclusion on the identification: based on the tests the customer performed, the expected identification is neisseria spp but based on 16s sequencing it could be a species close to neisseria meningitidis or neisseria polysaccharea species.The tested species is most likely not included in the vitek® ms knowledge base v3.2.The following system limitation is mentioned in the vitek® ms knowledge base user manual ref.161150-924-a 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 cause: - system limitation (species not present in the knowledge base v3.2).

• Brand Name: VITEK® MS
• Type of Device: VITEK MS INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, 38390 ; FR 38390
• MDR Report Key: 8907033
• MDR Text Key: 218542544
• Report Number: 9615754-2019-00061
• 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: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• 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: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1