MAUDE Adverse Event Report: BIOMERIEUX, SA 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) contacted biomérieux to report a misidentification of streptococcus anginosus as mycobacterium genavense in association with the vitek® ms instrument (knowledge base version 3.2).The customer stated that after one night incubation (14 - 20 hours), vitek ms identified the strain to mycobacterium genavense with good match.However, after a second night of incubation, streptococcus anginosus is identified properly.Typically, testing is performed from chocolate agar incubated in co2 atmosphere where streptococcus grows better.The customer stated the vitek ms was fine-tuned on (b)(6) 2019 and the organism identification issue appeared (b)(6) 2019.The customer indicated they do not report results to the physician before two (2) days of incubation; therefore no incorrect results have been reported and no patient treatment has been delayed.There is no indication or report from the laboratory or treating physician that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

A customer in finland contacted biomérieux to report a misidentification of streptococcus anginosus as mycobacterium genavense in association with the vitek® ms instrument (knowledge base version 3.2).The customer tested the isolate two more times and on a different vitek ms instrument after two nights of incubation.Both identifications obtained were streptococcus anginosus.An internal biomérieux investigation was performed using data provided by the customer.A review of the customer system and set up identified the customer's system was operational.However, the calibrator and sample spot preparation quality seemed to be non-optimal.The "all peaks" value of the sample spots are heterogeneous.This could be explained by a non-optimal spot preparation.The isolate was not submitted for investigation therefore the identification of streptococcus anginosus could not be confirmed.The incubation time for the first test was between 14 and 20 hours.The vitek ms workflow user manual states the recommended incubation time for bacteria is 18-72 hours.A test performed with culture incubated between 14 and 18 hours is considered off-label use.This investigation determined that the most likely causes of misidentification was non optimal spot preparation and operator error due to incorrect incubation time.

• Brand Name: VITEK® MS INSTRUMENT
• Type of Device: VITEK® MS INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, les grottes isere 38390 ; FR 38390
• MDR Report Key: 8544110
• MDR Text Key: 161306006
• Report Number: 9615754-2019-00031
• 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: 07/16/2019

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: 03/27/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 06/16/2019
• Supplement Dates FDA Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1