MAUDE Adverse Event Report: BIOMERIEUX SA VITEK® MS INSTRUMENT

Model Number 410895

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a misidentification associated with the vitek® ms instrument involving a patient sample (toe swab).The isolate was first tested using the vitek®2 instrument and the identification was citrobacter youngae (95%), with repeat testing identifying citrobacter amalonaticus (91%).The indole was positive, so the customer defined the vitek®2 result as citrobacter amalonaticus.The isolate was then tested using the vitek® ms instrument and the identification result was citrobacter freundii and enterobacter aerogenes, with repeat testing identifying citrobacter freundii.The final result reported to the physician was citrobacter amalonaticus.The customer indicated patient results were affected, as there was a delay of greater than 24 hours.In addition, the customer indicated it was unknown as to whether an incorrect result was reported to the physician as the correct result was unknown at that time.The customer stated the patient was not harmed or mistreated.The isolate and test reports were requested from the customer.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer from (b)(6) reported to biomérieux a misidentification associated with the vitek® ms instrument (udi (b)(4)).An investigation was performed.The customer's strain was returned.A 16s sequencing was performed and the result was citrobacter murliniae (100%).This species is not included in the vitek® ms knowledge base v2.0 used by the customer.It is also not included in the vitek® ms kb v3.0 or v3.2.The strain was tested internally on vitek® ms v2 (kb v2.0) and vitek ms v3 (kb v3.0) and results were: - vitek ms v2 kb v2.0: three (3) spots analyzed twice resulted in four (4) identifications to citrobacter werkmanii and two (2)identifications to citrobacter freundii - vitek ms v3 kb v3.0: three (3) spots gave identification to citrobacter werkmanii.The root cause of the misidentification (obtained by the customer or internally) is a system limitation.The expected species (citrobacter murliniae) is not included in the vitek® ms database v2.0.The system identification is based on a species pattern classification.Consequently, the system can give: - no identification (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 than expected) 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 than expected) when the spectrum acquired presents high level of similarity with multiple specific species patterns present in the database.Note that the knowledge base user manual mentions the following limitations: "testing of species not found in the database may result in an unidentified result or a misidentification.Note: 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.".

• Brand Name: VITEK® MS INSTRUMENT
• Type of Device: VITEK® MS INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6190525
• MDR Text Key: 62914916
• Report Number: 3002769706-2016-00518
• Device Sequence Number: 1
• Product Code: PEX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K124067
• 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: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 410895
• Other Device ID Number: 03573026359119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: FSCA 3305
• Patient Sequence Number: 1