MAUDE Adverse Event Report: BIOMERIEUX, S.A. VITEK® MS

Model Number 410895

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a misidentification of three strains in association with the vitek® ms ((b)(4)).The customer tested the three strains with vitek® ms and the result was no identification.The strains were then tested with vitek® 2 giving identifications.A gram stain was also performed.The results were: corynebacterium jeikium (vitek® 2 : 99%), gram +, bacteroides ovatus (vitek® 2 : 89%), gram -, sphingomonas paucimobilis vitek® 2: 96%), gram -.The strains identified with the vitek® 2 are present in the knowledge base of vitek® ms.The customer stated no wrong result was reported to a physician and there was no impact to patient results or treatment.There was a 24 hour delay for reporting results.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from (b)(6) reported to biomérieux that three strains were not identified in association with the vitek® ms (udi (b)(4) ) and were identified with vitek® 2.An investigation was performed.A review of data files confirmed the vitek ms system was operational during the test.Strain 1 (corynebacterium jeikium 99% on vitek 2): the organism was tested on 16s and rpob sequencing and it gave an identification to corynabacterium spp., which is not included in the vitek ms v3 (kb v3.0, v3.1 & v3.2) or in vitek 2.The vitek ms customer results were reproduced as no identification.In case of a species not being included in knowledge base, a "no identification" result on vitek ms is a correct result.The vitek ms v3 (kb v3.0, v3.1 & v3.2) performed as intended when testing this strain.Strain 2 (bacteroides ovatus 89% on vitek 2): it is not possible to confirm if the customer system gave an erroneous test result (no identification) or not.The customer strain is not available for investigation.Strain 3 (sphingomonas paucimobilis 96% on vitek 2) : it is not possible to confirm if the customer system gave an erroneous test result (no identification) or not.The customer strain is not available for investigation.The knowledge base user manual ref.161150-556- b for vitek ms clinical use v3.0 mentions the following limitations: "testing of species not found in the database may result in an unidentified result or a misidentification." fsca 3305 (vitek_ms_v2.0_and_v3.0_system_limitations) was issued in february 2017 to inform the customers about this system limitation.On vitek 2, there is a product limitation concerning the species not included in the kb.Testing of unclaimed species may result in an unidentified result or a misidentification.There was no problem with vitek ms system as the strain is not included in the knowledge base.Vitek ms gave a no identification as expected.

• Brand Name: VITEK® MS
• Type of Device: VITEK® MS
• Manufacturer (Section D): BIOMERIEUX, S.A.; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX, S.A.; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6545878
• MDR Text Key: 74491917
• Report Number: 3002769706-2017-00116
• Device Sequence Number: 1
• Product Code: PEX
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 10/06/2017
• 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: Unknown
• Patient Sequence Number: 1