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

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  

Event Description

A customer in (b)(6) notified biomérieux of a misidentification of pseudomonas aeruginosa as mycobacterium tuberculosis when testing a patient isolate with the vitek® ms (ref 410895, serial (b)(4).Repeat analysis of the isolate with the vitek® ms obtained the expected identification of pseudomonas aeruginosa.The customer reported that there was no patient impact.No incorrect result was reported to the physician.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was initiated for a customer report of a misidentification of pseudomonas aeruginosa as mycobacterium tuberculosis when testing a patient isolate with the vitek® ms (ref 410895, serial (b)(6).The customer's strain was not available for submittal for the investigation.The data submitted by the customer was analyzed.*conclusion on the system: the customer's system was operational during the test.However, one mandatory acceptance criterion ("median of number of peaks" ) was not achieved during the fine tuning before the test.A new fine tuning was performed on 30aug2019, and it was in conformance.*conclusion on spot preparation quality: the customer's spot preparation quality was not optimal.The sample "all peaks" values was quite heterogeneous (30 and 82 for the same sample).This could be explained by a non-optimal spot preparation (culture, spot, different operator.).*conclusion on the identification: according to this analysis and morphological aspect of the strain observed, the most probable identification is pseudomonas aeruginosa.If the issue occurs again, this identification should be confirmed by reference method (sequencing).*suspected cause retained: - non-optimal fine tuning.- non-optimal sample 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: 9146244
• MDR Text Key: 219786137
• Report Number: 9615754-2019-00093
• 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: 10/31/2019

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: 410895
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 10/04/2019
• Supplement Dates FDA Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1