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

Catalog Number 21346

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An internal investigation was performed.The internal biomérieux cap (b)(4) 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 (b)(4)): 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 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 nh id test kit.The customer tested the sample multiple times on the vitek nh id and the gn card, and obtained an identification of moraxella group, when the expected result was acinetobacter lwoffii.

• Brand Name: VITEK® 2 NH ID TEST KIT
• Type of Device: VITEK® 2 NH ID 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: 7954583
• MDR Text Key: 125464665
• Report Number: 1950204-2018-00422
• Device Sequence Number: 1
• Product Code: JST
• UDI-Device Identifier: 00357302614435
• UDI-Public: 0357302614435
• 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
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2019
• Device Catalogue Number: 21346
• Device Lot Number: 2450570403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2017
• 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