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

An investigation was performed.Conclusion on the system: the system was operational during the tests (fine tuning acceptance criteria conformed).The customer's spot preparation was not optimal (the "all peaks number" from the calibrator strain is heterogeneous).Conclusion on the identification: regarding the information provided, it is not possible to conclude on the identification obtained by the customer.Without any data on the strains, it is not possible to perform further investigation.Suspected cause of the issue: poor spot preparation technique confirmed by the level 1 investigation.

Event Description

A customer in (b)(6) reported misidentifications and calibration failures in association with the vitek® ms instrument.The customer reported that the following isolates were misidentified: id (b)(6) pseudomonas - identified as s.Aureus, id (b)(6) heamophilus - identified as s.Aureus, id (b)(6) s.Aureus - identified as s.Pneumonaie, id (b)(6) chryseobacterium - identified as heamophilus.The customer stated they were confirming all identifications from the vitek ms prior to reporting.The customer stated that some isolates had repeat testing and obtained the correct identification while others had other tests performed.The customer stated that no incorrect results were reported as the users recognized the error(s).There is no indication or report from the hospital or treating physician to biomérieux that the misidentifications led to any adverse event related to a patient's state of health.The customer mentioned that there were many new technicians manually entering sample ids on the preparation station during set up.

• 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: 7345767
• MDR Text Key: 103158935
• Report Number: 3002769706-2018-00041
• Device Sequence Number: 1
• Product Code: PEX
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• 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
• Date Manufacturer Received: 02/15/2018
• 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: Unknown
• Patient Sequence Number: 1