MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 GN 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 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.(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.
Event or Problem Description
A customer in (b)(6) reported a misidentification of an acinetobacter lwoffii cap survey strain (d-09) as moraxella group with the vitek® 2 gn test kit (2410478203).The customer reported a result of moraxella group and found out later that the expected result was acinetobacter lwoffi, acinetobacter junii (lwoffi/johnsonii), or acinetobacter sp.The biomérieux local field application specialist tested the isolate on the vitek systems of the reporting customer and another customer, and the result was moraxella group.The isolate was identified as acinetobacter lwoffii with vitek ms.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: VITEK® 2 GN TEST KIT
• Common Device Name: VITEK® 2 GN TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 8025947
• Report Number: 1950204-2018-00454
• Device Sequence Number: 11172786
• Product Code: LQM
• UDI-Device Identifier: 03573026131913
• UDI-Public: 03573026131913
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2018

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: 03/19/2019
• Device Catalogue Number: 21341
• Device Lot Number: 2410478203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1