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

Catalog Number 21342

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in (b)(6) reported a misidentification of a quality control streptococcus pneumoniae strain (atcc 49619) as streptococcus thoraltensis, in association with the vitek® 2 gp test kit (lot 2420563203).A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed due to a misidentification of streptococcus pneumoniae atcc 49619 on the vitek®2 v7.01 gp id card.The expected identification to s.Pneumoniae was confirmed on vitek ms v3 ( knowledge base v3.0).On the vitek 2 (v7.01) gp card, one card of customer lot n1 (cl1: 2420314203), one card of customer lot n2 (cl2: 2420563203) and one card of a random lot (rl: 2420571103) were tested from tss subculture.These tests gave a very good identification to s.Pneumoniae with all lots.The customer misidentifications were not reproduced in-house on three lots tested.Note: organisms used for qc testing (such as s.Pneumonia atcc 49619) do not necessarily need to give the correct identification; instead, the purpose of testing a qc organism is to check well reactions.A review of the lab reports submitted by the customer demonstrated multiple atypical reactions for an identification of s.Penumoniae according to gp knowledge base.An increased number of atypical reactions can indicate contamination, mixed culture, reduced strain variability, use of non-recommended media, or other set up errors.The vitek 2 gp card performed as intended and no further action is required.

• Brand Name: VITEK® 2 GP TEST KIT
• Type of Device: VITEK® 2 GP TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum rd; hazelwood, MO 63042
• MDR Report Key: 7392933
• MDR Text Key: 104686739
• Report Number: 1950204-2018-00127
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420563203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2017
• 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