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

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 from the united states reported a misidentification of a cap survey strain when testing with the vitek® 2 gn id card (ref (b)(4)).The expected id was acinetobacter lwoffi.The gn id card identified the strain as moraxella group.There was no patient involvement as the event pertained to a cap survey sample.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A us customer reported a misidentification of an acinetobacter lwoffii cap survey strain (d-09) as moraxella group with the vitek® 2 gn test kit.An investigation was performed.The internal biomerieux cap d-09 (2018) survey strain was subcultured to tsab and macconkey agar and incubated to 35-37°c for 20-22 hours.A second subculture was performed and testing included individual organism suspensions with gn cards from four different gn card lots in duplicate as well as vitek ms.911691 (biomerieux internal cap d-09 strain): the strain grew on mac agar as a non-lactose fermenting isolate.All eight gn cards tested resulted in low discrimination identifications of acinetobacter lwoffii/moraxella group.Vitek ms resulted in an identification of acinetobacter lwoffii with a 99.9% confidence value.As a.Lwoffii was part of the low discrimination call on all gn cards tested, vitek 2 cards are performing as expected.No further action is required.Quality systems performed a search for all complaints against gn card lots 2410402203, 2410515403, 2410433103 and 2410515203, and did not indicate any trends for these card lots.The most recent quarterly trend report, q1 2018, did not identify this complaint as a systemic quality issue.

• Brand Name: VITEK® 2 GN ID TEST KIT
• Common Device Name: VITEK® 2 GN ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 7897212
• Report Number: 1950204-2018-00384
• Device Sequence Number: 169337
• Product Code: LQM
• UDI-Device Identifier: 03573026131913
• UDI-Public: 03573026131913
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/30/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2019
• Device Catalogue Number: 21341
• Device Lot Number: 2410515403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1