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 Date 02/06/2018

Event Type  malfunction  

Event Description

A customer in the netherlands contacted biomérieux to report a misidentification of actinomyces species in association with the vitek® ms system.Vitek ms obtained the following results for three tests: spot k2: single choice to streptococcus anginosus; spot k3: single choice to streptococcus constellatus; spot k4: single choice to actinomyces meyeri.Testing via alternate method (bruker) obtained actinomyces odontolyticus.Reference method testing (e.G.Sequencing) was not performed.The customer stated that the vitek ms results were not reported to the treating physician and had no impact on patient treatment decisions.There have been no adverse impact on patient health.Based on review of the mzml log files and calibration logs, preliminary analysis indicates the customer's slide spot preparation is non-optimal and heterogeneous; hence the inconsistent organism identifications.In addition, the fine-tuning of the instrument does not meet all specified criteria.Biomérieux investigation has been initiated to perform vitek ms instrument fine-tuning and provide additional spot preparation training for the customer.This will be followed by testing of the same specimen to monitor for consistency and accuracy of result.

Manufacturer Narrative

A customer in the netherlands had contacted biomérieux to report a misidentification of actinomyces species in association with the vitek® ms system.An internal biomérieux investigation was performed.Investigation findings: the vitek ms system was not operational during the tests (fine tuning acceptance criteria not in conformance).Based on the analysis of the results obtained from calibrator spots, the sample spot preparation was quite heterogeneous.The customer's spot preparation was not optimal.Results interpretation: regarding the information provided, the most probable identification is actinomyces odontolyticus (bruker).However, in order to confirm the identification to the species level, a reference identification method has to be done (sequencing).Following the investigation, two actions were performed by a biomérieux representative: a new fine tuning of the customer's instrument was performed on 22-feb-2018."customer training materials" were provided to help the customer improve their spot preparation technique.After these two actions, the customer performed retesting and obtained the suspected identification (actinomyces odontolyticus) for three of the four tests made.The fourth test gave no identification.There was no misidentification; vitek ms worked as intended.Probable causes: non-optimal spot preparation.Non-optimal fine tuning.

• 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: 7326793
• MDR Text Key: 102336642
• Report Number: 3002769706-2018-00034
• 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: 04/17/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 03/09/2018
• Supplement Dates Manufacturer Received: 03/20/2018
• Supplement Dates FDA Received: 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1