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 in the united states reported a misidentification of an acinetobacter lwoffii cap survey strain (d-09) as moraxella group in association with the vitek® 2 gn id test kit (lot 2410474203).The customer stated they reported the identification as moraxella group and the expected result was acinetobacter lwoffii.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer in the united states reported a misidentification of an acinetobacter lwoffii cap survey strain (d-09) as moraxella group in association with the vitek® 2 gn id test kit (lot 2410474203).An investigation was performed.The customer's cap d-09 strain and the internal biomérieux cap d-09 survey strain were 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 the customer lot (2410474203) and a random lot (2410593203) in duplicate as well as vitek ms.911728 (customer's cap d-09 strain): the strain grew on mac agar as a non-lactose fermenting isolate.All 4 gn cards tested resulted in low discrimination acinetobacter lwoffii/moraxella group.Vitek ms resulted in an identification of acinetobacter lwoffii with a 99.9% confidence value.911691 (biomérieux internal cap d-09 strain): the strain grew on mac agar as a non-lactose fermenting isolate.All 4 gn cards tested resulted in low discrimination acinetobacter lwoffii/moraxella group.Vitek ms resulted in an identification of acinetobacter lwoffii with a 99.9% confidence value.A review of the customers moraxella group data showed no positive reactions, demonstrating one atypical negative reaction (tyra) for an identification of a.Lwoffii according to the gn knowledge base.As a.Lwoffii was part of the low discrimination call on gn cards, cards are performing as expected for both strains.No further action is required.

• 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: 7890169
• Report Number: 1950204-2018-00375
• Device Sequence Number: 1908518
• Product Code: LQM
• UDI-Device Identifier: 03573026131913
• UDI-Public: 03573026131913
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/29/2018

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: 03/15/2019
• Device Catalogue Number: 21341
• Device Lot Number: 2410474203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1