MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK® MS; VITEK MS INSTRUMENT

Model Number 4700394

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from (b)(6) notified biomérieux of obtaining a discrepant identification result when testing with the vitek® ms instrument system (ref.(b)(4), serial number for instrument not available).Vitek ms obtained identification of klebsiella variicola (97.7%).Upon repeat testing, the customer reported that the correct identification of klebsiella pneumoniae (99.9%) was obtained.The customer reported that there was no patient harmed or treated incorrectly due to the discrepant result.The customer stated there was no delay in reporting results.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in singapore regarding a discrepant identification result when testing with the vitek® ms instrument system.Vitek ms obtained identification of klebsiella variicola (97.7%).Upon repeat testing, the customer reported that the correct identification of klebsiella pneumoniae (99.9%) was obtained.Biomérieux internal investigation was conducted.Conclusion on the system: based on the data files obtained from the customer's system, the system was operational during the tests.The last fine-tuning was done on 16-sep-2019.Conclusion on spot preparation quality: the customer's spot preparation quality is not optimal.The sample and calibrator "all peaks" values are quite heterogeneous.This could be explained by a non-optimal spot preparation (culture, spot, different operator, etc.).Conclusion on the identification: according to customer data, the most probable identification is klebsiella pneumonia.Klebsiella variicola identification is obtained from the spectra having the lower score (-0.38).Moreover, the analysis of the spectra indicates that the amount of bad peaks is high compared to the good peak (34 bad peaks and 32 good peaks).The investigation observed that the reduction of the number of small peaks allows to identify the isolate correctly.This phenomenon could also be due to a non-optimal fine-tuning.As the fine-tuning report from fine-tuning made on 16-sep-2019 is not available, it is not possible to confirm.However, it will be retained as a potential cause of the issue.Suspected cause(s): non optimal spot preparation by the customer.Non optimal fine-tuning.Based on complaint record review from january 2016, no other complaint has been recorded for a similar identification issue (klebsiella variicola instead of klebsiella pneumonia).Without the fine-tuning report from 16-sep-2019, available evidence suggests the vitek ms system was performing within specification.The most likely cause of the reported issue user error (non-optimal spot preparation).

• Brand Name: VITEK® MS
• Type of Device: VITEK MS INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, 38390 ; FR 38390
• MDR Report Key: 9226404
• MDR Text Key: 220565163
• Report Number: 9615754-2019-00114
• Device Sequence Number: 1
• Product Code: PEX
• 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: 12/03/2019

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: 4700394
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: 11/04/2019
• Supplement Dates FDA Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1