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 Type  malfunction  

Manufacturer Narrative

A biomérieux internal investigation was performed.*conclusion on the system - system was operational during the test (fine tuning acceptance criteria conformed).- the customer's spot preparation is not optimal (the "all peaks number" is occasionally quite heterogeneous for the analyzed period).*conclusion on the identification: it is not possible to conclude on the identification for the following reasons : -the strain is not available for investigation -the customer cannot be able to give the sample id and the date of the tests notes : -vitek ms identified the strain to actinomyces (no information about the species name) but the identification was not consistent with the gram staining and the clinical context (symptom,.).-for future similar cases, the customer will identify by pcr all actinomyces results given by vitek ms.*suspected cause of the issue : regarding the information provided, no suspected cause could be defined.

Event Description

A customer in (b)(6) reported a misidentification of a corynebacteria species as a single choice actinomyces in association with the vitek® ms instrument.The customer reported the vitek ms gave an identification of a single choice actinomyces (99.9%) multiple times and this was not consistent with the clinic and the gram staining results which were in favor of a corynebacteria species.No other identification method was used to confirm the result.No wrong result was communicated to the physician as the identification given by vitek ms was not consistent with the clinic and gram staining results.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: ellen weltmer ; 100 rodolphe street; durham, NC 27712
• MDR Report Key: 7341369
• MDR Text Key: 102600768
• Report Number: 3002769706-2018-00037
• Device Sequence Number: 1
• Product Code: PEX
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/15/2018

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: 02/14/2018
• Initial Date FDA Received: 03/15/2018
• 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: N
• Patient Sequence Number: 1