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

Catalog Number	21346
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 sample (sputum), as moraxella catarrhalis (92%) in association with the vitek® 2 nh test kit.The nh card result had low discrimination moraxella catarrhalis/campylobacter coli with contraindicating biopatterns, so the customer tested the isolate on the vitek gn card and obtained the result of moraxella group.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 nh test kit.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.

• Brand Name: VITEK® 2 NH TEST KIT
• Common Device Name: VITEK® 2 NH TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 7870611
• Report Number: 1950204-2018-00358
• Device Sequence Number: 1835732
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 05/22/2019
• Device Catalogue Number: 21346
• Device Lot Number: 2450542103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 09/12/2018
• 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