MAUDE Adverse Event Report: BIOMERIEUX SA VITEK® MS

Model Number 410895

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2018

Event Type  malfunction  

Manufacturer Narrative

A biomérieux internal investigation was performed.* investigation findings: =>system was operational during tests performed (fine tuning acceptance criteria were conformed).=>based on the analysis of the results obtained from calibrator spots, the "all peaks number" is quite homogeneous.The sample spot preparation was good.* results interpretation: =>regarding the information provided, the most probable identification is salmonella typhi.=> vitek ms gave salmonella group instead of the suspected identification to the species level salmonella typhi.In this case, as described in the vitek ms v3.0 knowledge base clinical use 161150-556 - b, for salmonella group and all salmonella identifications, you have to : - handle isolate with extreme caution and send to a reference laboratory for identification confirmation following your laboratory's protocol and/or country regulations.- confirm identification by serological tests.* probable cause: =>limitation of the knowledge base v3.0 clinical regarding salmonella.

Event Description

A customer in (b)(6) reported a twice misidentified salmonella ser typhi strain from blood culture, as salmonella group in association with the vitek® ms instrument on (b)(6) 2018.The customer stated the serological test result was not consistent with the vitek ms, so the isolate was tested with the vitek 2 gn card which identified salmonella ser typhi.The customer stated they subcultured the positive cultures on bap, mac and tsi slant, and the tsi indicated s.Typhi.The customer indicated that there was no incorrect result reported, and no reporting delay or impact to patient therapy.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.

• Brand Name: VITEK® MS
• Type of Device: VITEK® MS
• Manufacturer (Section D): BIOMERIEUX SA; 3 route de port michaud; la balme les grottes isere 383; FR
• Manufacturer (Section G): BIOMERIEUX SA; 3 route de port michaud; la balme les grottes isere 383; FR
• Manufacturer Contact: debra broyles ; 595 anglum road; hazelwood, MO 63042 ; 3147318805
• MDR Report Key: 7480890
• MDR Text Key: 107208382
• Report Number: 3002769706-2018-00063
• Device Sequence Number: 1
• Product Code: PEX
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: DEN130013
• 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
• Report Date: 05/02/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 05/02/2018
• 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