MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK MASS SPECTROMETER; 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) notified biomérieux of misidentification results when testing an isolate with vitek® ms (reference 410895).Vitek ms obtained an identification of streptococcus pyogenes.The customer performed langfeld strep group kit testing, which categorized the organism as a group g streptococcus.The customer reported that no patient results were affected and no wrong results were reported to a physician.They reported that there was no patient harmed or treated incorrectly.There was no delay in reporting results.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer from the united kingdom notified biomérieux of misidentification results when testing an isolate with vitek® ms (reference 410895).Vitek ms obtained an identification of streptococcus pyogenes.The customer performed langfeld strep group kit testing, which categorized the organism as a group g streptococcus.An internal biomérieux investigation was performed.Investigation findings: system was operational during the testing.The customer's spot preparation was not optimal (the "all peaks number" from the calibrator strain is quite heterogeneous).Results interpretation: regarding the information provided, the most probable identification is group g streptococcus.No information about the species name.To confirm the identification, a molecular method has to be performed (reference method).The customer's strain was required to continue the investigation; however, it was not available.Therefore, no further investigation could be performed.Suspected cause of the issue : based on the data analyzed, the most suspected cause of the issue is non-optimal spot preparation.

• Brand Name: VITEK MASS SPECTROMETER
• Type of Device: VITEK® MS¿
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• MDR Report Key: 7462870
• MDR Text Key: 107091839
• Report Number: 3002769706-2018-00058
• Device Sequence Number: 1
• Product Code: PEX
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• PMA/PMN Number: DEN130013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1