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
Additional Manufacturer Narrative
An internal investigation was performed.The internal biomérieux 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.(b)(4) (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.Some customers associated with this internal strain investigation reported misidentifications when testing this strain with the vitek 2 nh card, however the nh card knowledge base does not include a.Lwoffii as a claimed species so either an unidentified result or misidentification may occur.The following limitation is contained in the product labeling: testing of unclaimed species may result in an unidentified result or a misidentification.
Event or Problem Description
A customer in the united states reported a misidentification of an acinetobacter lwoffii survey sample (d-9) as moraxella group in association with the vitek® 2 gn id test kit.The customer tested the sample on the vitek gn id card, and obtained an identification of moraxella group, when the expected result was acinetobacter lwoffii.

• 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: 7954584
• Report Number: 1950204-2018-00421
• Device Sequence Number: 427781
• Product Code: LQM
• UDI-Device Identifier: 03573026131913
• UDI-Public: 03573026131913
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 10/10/2018

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: 04/25/2019
• Device Catalogue Number: 21341
• Device Lot Number: 2410515203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1