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

Catalog Number 21346

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event 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.

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
• Type of Device: VITEK® 2 NH TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: debra broyles ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 7870611
• MDR Text Key: 120732051
• Report Number: 1950204-2018-00358
• Device Sequence Number: 1
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2019
• Device Catalogue Number: 21346
• Device Lot Number: 2450542103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 09/12/2018
• Supplement Dates Manufacturer Received: 10/04/2018
• Supplement Dates FDA Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1