MAUDE Adverse Event Report: BIOMERIEUX, INC 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 biomerieux of a misidentification of a proteus mirabilis strain in association with the vitek® ms.Initial testing resulted in no identification.The customer repeated the test using the same slide and the result was klebsiella pneumoniae (99.9%).The customer stated the colony looked like a proteus mirabilis.The test was repeated the next day with a new slide and the result obtained was proteus mirabilis.The strain was cultured on chromid® cps® elite media.The customer reported that incorrect results were not reported to the physician and there was no impact to patient treatment and no delay for reporting results.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: the system is operational during customer testing.Reprocessing of the same with vitek® ms knowledge base (kb) v3.0, v3.1 and next vitek® ms kb v3.2 shows improved results.There were no "no identification" or "not enough peaks" as a result for tests run after (b)(6) 2016 and no misidentifications were reported.The reason for the improved results is due to improvements made from kb v3.0 regarding the acceptance criteria to give an identification (the acceptance criteria is more stringent from v3.0 and allows to reject the identification and reduce the number of misidentification results).The likely root cause of the issue is sample preparation.The analysis of the graph of ecal mzml files indicates that "all peaks number" is heterogeneous.The first spectra analyzed on (b)(6) 2016 and leading to noid had 39 peaks, whereas the spectra analyzed on (b)(6) 2016 and leading to the expected id has more peaks: 66 (all peaks).Updates to vitek® ms v3 kb v3.0 which is more robust regarding the spot quality and allows to reduce the number of misidentification due to this cause.This version has been launched in july 2016 through fca 3031.

• Brand Name: VITEK® MS
• Type of Device: VITEK® MS
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6439063
• MDR Text Key: 71054422
• Report Number: 3002769706-2017-00054
• Device Sequence Number: 1
• Product Code: PEX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K124067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2017

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
• Other Device ID Number: 03573026359119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2016
• Initial Date FDA Received: 03/28/2017
• Supplement Dates Manufacturer Received: 06/30/2017
• Supplement Dates FDA Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1