MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VITEK 2 NH-ID TEST KIT; VITEK® 2 NH-ID TEST KIT

Catalog Number 21346

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

Patient Problem Misdiagnosis (2159)

Event Type  Injury  

Event Description

A customer in (b)(6) notified biomerieux of the misidentification of a patient campylobacter fetus isolate as campylobacter coli in association with the vitek® 2 nh-id test kit (ref.(b)(4), lot 2451162203).The patient isolate sourced from an aortic prosthesis was subcultured onto chocolate agar then tested using lot 2451162203.Lot 2451162203 identified the isolate as campylobacter coli.The customer also sent the patient isolate to another laboratory for confirmatory testing using the maldi-tof test method; an identification of campylobacter fetus was obtained.Review of the customer¿s lab reports showed an increased number of atypical well reactions that can indicate use of non-recommended media.Biomerieux customer service advised the customer that use of chocolate agar is not recommended for testing of campylobacter with the vitek® 2 nh-id test kit.The vitek® 2 nh-id test kit instructions for use(ifu) "culture requirements table" states the following agar types are validated for culturing campylobacter: trypticase soy agar with 5% sheep blood, columbia blood agar with 5% sheep blood, columbia horse blood agar, and trypticase soy agar with 5% horse blood.The ifu also states use of culture media other than the recommended types must be validated by the customer laboratory for acceptable performance.A biomerieux field application specialist (fas) visited the customer site and noted multiple errors in the customer¿s workflow.These workflow errors included: cleaning the dispensette with alcohol, not wearing gloves when handling vitek® 2 cards, cleaning the instrument optics monthly instead of weekly, inverting the cell suspension only 2-3 times prior to testing.The fas advised the customer to stop cleaning the dispensette with alcohol, clean the instrument optics weekly, use a vortex mixer when preparing cell suspension, and to always wear gloves when handling vitek® 2 cards.The fas requested the customer retest the patient isolate following these recommendations using validated media.However, the customer has not provided any response to this request.Additionally, it was identified the customer incubated the chocolate agar culture for 48 hours before optimal growth was observed.The recommended age of culture for strains tested with the nh id card is 18-24 hours.This is considered off-label use.The customer has not complied with biomerieux request for incubation temperature and environment (aerobic/non-aerobic, co2/non-co2).There is patient impact; the customer stated the patient was provided treatment for approximately two (2) days based on the incorrect campylobacter coli identification.The customer indicated treatment of campylobacter fetus would have been different from the treatment provided based on the campylobacter coli result.Despite this, the customer confirms that there was no permanent or irreversible damage to the patient because the treatment was modified rapidly as a result of the vitek ms report from their sister lab.Biomerieux will initiate an internal investigation.

Manufacturer Narrative

This report was initially submitted following notification from a customer in canada regarding a misidentification of a patient campylobacter fetus isolate as campylobacter coli in association with the vitek® 2 nh-id test kit (ref.21346, lot 2451162203).A biomerieux field application specialist (fas) visited the customer site and noted multiple errors in the customer¿s workflow.Fas recommendations for the customer after site visit: 1.Stop cleaning the tip of the dispensette with alcohol.2.Use a vortex to obtain better homogeneity.(they were only inverting 2-3 times).3.Wear gloves when handling vitek cards.(they were not wearing gloves).4.Clean the optics once a week.(they were cleaning once a month, however for troubleshooting they had cleaned optics more often.) the customer¿s strain was not requested due to off label use and lack of repeat testing.No additional troubleshooting information (including incubation conditions) was provided by the customer.Without strain submittal it is not possible to further evaluate the cause of the misidentification.A comparison of the customer¿s card reaction results against expected reaction results for c.Fetus revealed two (2) atypical positive reactions (odc, iglm) that led to the misidentification.An increased number of atypical reactions can indicate a strain with decreased viability, contamination, mixed culture, use of non-recommended media, or other user set up issues.Vitek® 2 nh id lot 2451162203 met final qc release criteria and passed qc performance testing.

• Brand Name: VITEK 2 NH-ID TEST KIT
• Type of Device: VITEK® 2 NH-ID TEST KIT
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 11288666
• MDR Text Key: 234262263
• Report Number: 1950204-2021-00015
• Device Sequence Number: 1
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (y/n): N
• PMA/PMN Number: C1 EXEMPT
• 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: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 21346
• Device Lot Number: 2451162203
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 02/16/2021
• Supplement Dates FDA Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention