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 cap survey sample (d-9) as moraxella group in association with the vitek® 2 gn id test kit.The customer tested the sample multiple times on the vitek gn id and the nh 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: 7954582
• Report Number: 1950204-2018-00420
• Device Sequence Number: 18882925
• Product Code: LQM
• UDI-Device Identifier: 03573026131913
• UDI-Public: 03573026131913
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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 an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2019
• Device Catalogue Number: 21341
• Device Lot Number: 2410433103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2018
• 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