MAUDE Adverse Event Report: BIOMERIEUX SA VITEK® MS; VITEK® MASS SPECTROMETER

Model Number 410895

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not received from customer.

Event Description

A customer in (b)(6) contacted biomérieux to report a misidentification of atcc® pediococcus acidilactici as gemella marbillorum in association with the vitek® ms system.Repeat testing obtained the same result.The customer also tested the strain via 16s sequencing and received the expected organism identification of pediococcus acidilactici.The associated mzml and calibration data files were collected and submitted to the local support team.The mzml files were reviewed and processed through a vitek® ms knowledge base simulator for software versions 2.0, 3.0 (clinical), and 3.1 (industry).The results were as follows: vitek® ms kb v2 : singlechoice - gemellamorbillorum, vitek® ms kb v3.0 clinic : singlechoice - pediococcus acidilactici, vitek® ms kb v3.1 industry : singlechoice - pediococcus acidilactici.Correct identification are obtained with the vitek® ms kb v3.0 (clinic) and vitek® ms kb v3.1 (industry).The analysis of the data regarding fine-tuning indicates that the system is functioning properly.Fine-tuning criteria are met.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to any patient's state of health.There was no patient directly associated with the atcc® sample.Culture submittal was requested by biomérieux for internal investigation.Biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) contacted biomérieux to report a misidentification of atcc® pediococcus acidilactici as gemella marbillorum in association with the vitek® ms system.An internal biomérieux investigation was performed.Vitek® ms results : gemella marbillorum expected identification : pediococcus acidilactici jcm8798t (culture collection center jmc) + customer's 16s result.Note: pediococcus acidilactici is included in vitek ms v2.0 knowledge base (kb).Customer tested several times by using different colonies but the results were the same.Customer incubated this pediococcus acidilactici jcm8798t under the following conditions: - pure culture -air: anaerobic -temp.: 30 degrees -time period: 48 hours -culture media: mrs (ph 5.5).There was no patient directly associated as the sample was an atcc® strain.Investigation conclusion: this complaint is the first complaint recorded for a misidentification of pediococcus acidilactici since the launch of the product.The misidentification was caused by: - four (4) bad reference spectra used to build the current vitek® ms kb, these spectra have been detected and are already removed from next kb v3.0.This has been confirmed by the investigation: customer's spectra reprocessed with next kb gave the correct identification results.- customer's spectra calibrated manually to suppress this defect gave low discrimination results (pedio.Acidilactici/gem.Morbillorum) in v2.0 instead of a misidentification.Note that the risk associated with this software defect has been assessed to minor for vitek® ms v2 and has already been corrected with vitek® ms v3.The root causes of the issue are related to the design of the system.Its improvement with a cleaning of the kb and the correction of the defect with the release of the new version vitek® ms v3 (jun2016) prevents a similar event to reoccur.

• Brand Name: VITEK® MS
• Type of Device: VITEK® MASS SPECTROMETER
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 5973099
• MDR Text Key: 55570834
• Report Number: 3002769706-2016-00346
• Device Sequence Number: 1
• Product Code: PEX
• Combination Product (y/n): N
• PMA/PMN Number: K124067
• 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: 08/25/2016

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
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 09/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2016
• 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