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 Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biomérieux of a misidentification of shigella sonnei as salmonella enterica ssp diarizonia when testing a (b)(6) survey sample with the vitek® 2 gn id test kit (ref.21341, lot 2410762203).The expected identification for the cap survey sample is shigella sp or shigella sonnei.Repeat testing using the vitek 2 gn id test kit identified the sample as salmonella enterica ssp diarizonia.The customer performed analytical profile index (api) and biofire® filmarray® testing and the sample was identified as shigella.As the sample was from a (b)(6) survey, there is no patient involved.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An investigation was completed in response to a customer complaint of a misidentification of shigella sonnei as salmonella enterica ssp diarizonia when testing a college of american pathologists (cap) survey sample (d-04 2019) with the vitek®2 gn id test kit (ref.21341, lot 2410762203).The expected identification for the cap survey sample is shigella sp or shigella sonnei.Since the customer's strain was not available to be sent for investigational testing, an internal biomérieux cap d-04 2019 survey strain was tested.Investigational testing included individual organism suspensions with vitek® 2 gn id test kit cards from the customer's lot (2410762203) and a random lot (2410784103), in duplicate, as well as the api 20 e test strip.All identifications obtained by the vitek® gn id test kit from both the customer's lot and the random lot were excellent identifications of shigella sonnei.The api® 20e strip resulted in a very good identification of shigella sonnei.A review of the customer's salmonella results demonstrated one atypical positive reaction (h2s) for an identification of shigella sonnei according to the gn knowledge base.Atypical positive reactions can indicate contamination, mixed culture, use of non-recommended media or other user set up error.It should be noted that any identification of salmonella/shigella 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 sp.And shigella sp.The misidentification was not reproduced internally.Gn lot #2410762203 met final qc release criteria.This lot passed qc performance testing.Vitek 2 gn cards are performing as expected for this strain.

• 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: 8841089
• Report Number: 1950204-2019-00240
• Device Sequence Number: 18911692
• Product Code: LQM
• UDI-Device Identifier: 03573026131913
• UDI-Public: 03573026131913
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 10/02/2019

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: 12/28/2019
• Device Catalogue Number: 21341
• Device Lot Number: 2410762203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1