MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 GN ID TEST KIT; GN TEST KIT VTK2 20CARDS

Catalog Number	21341
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biomérieux of a misidentification result of escherichia coli (e.Coli) as salmonella enterica ssp diarizonae when testing a patient urine sample with the vitek®2 gn id test kit (reference 21341, lot 2410809103).Repeat testing using the vitek 2 gn id test kit was performed two additional times; both repeat tests identified the isolate as salmonella enterica ssp diarizonae.The customer also sent the isolate out for maldi tof testing to a reference and state laboratory.Both maldi tof assays identified the isolate as e.Coli.The reference laboratory also tested the isolate using biochemical tests, which also identified the isolate as e.Coli.The customer stated that although treatment was provided for the incorrect identification result, the treatment was effective and no medical intervention was required.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in the united states regarding a misidentification result of escherichia coli (e.Coli) as salmonella enterica ssp diarizonae when testing a patient urine sample with the vitek® 2 gn id test kit (reference 21341, lot 2410809103).Repeat testing using the vitek 2 gn id test kit was performed two additional times; both repeat tests identified the isolate as salmonella enterica ssp diarizonae.Biomérieux investigation was conducted.The customer's submitted strain was sub-cultured.A second sub-culture was performed and testing included individual organism suspensions with gn id cards from the customer's lot (2410809103) and a random lot (2410984203) in duplicate, as well as vitek ms and api® 20e rapid test kit.Vitek 2 testing was performed with software versions 7.01 and 8.01.- all gn id cards tested software versions 7.01 and 8.01) resulted in very good identifications of e.Coli.- vitek ms identified the strain as e.Coli with a 99.9% confidence value.- api 20e rapid also resulted in a very good identification of e.Coli (99.4%).A review of the customer's salmonella enterica results demonstrated one atypical positive reaction (h2s) for an identification of e.Coli according to the gn knowledge base.Atypical reactions can indicate contamination, mixed culture, use of non-recommended media or other user set up error.Any identification of salmonella spp.Should be confirmed with another method such as serology.The gn lab report prints the message "confirm by serological tests" for any identification of salmonella spp.Vitek 2 gn id lot # 2410809103 met final qc release criteria.This lot passed qc performance testing.No ncmrs were written against the lot.Ncmrs were reviewed for the last 13 months (11sep2018 to 11oct2019).No ncmrs were written for the gnid card for performance issues.The investigation concluded the vitek 2 gn id cards are performing as expected.

• Brand Name: VITEK® 2 GN ID TEST KIT
• Common Device Name: GN TEST KIT VTK2 20CARDS
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 9146265
• Report Number: 1950204-2019-00293
• Device Sequence Number: 2656300
• Product Code: LQM
• UDI-Device Identifier: 03573026131913
• UDI-Public: 03573026131913
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2020
• Device Catalogue Number: 21341
• Device Lot Number: 2410809103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1