MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 GRAM POSITIVE TEST KIT; 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) notified biomérieux of recurrent misidentification of their qc strain, nctc 12697 enterococcus faecalis, in association with vitek® 2 gp id test kit (ref.21342, lot 2420330113).The vitek® 2 card identified this strain as enterococcus faecium.There is no indication or report from the laboratory that the discrepant results led to any adverse event related to any patient's state of health.There was no patient associated with the qc strain.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) notified biomérieux of recurrent misidentifications of enterococcus faecalis qc strains as enterococcus faecium, in association with vitek® 2 gp id test kit.An investigation was performed.The intended identification to enterococcus faecalis was confirmed on vitek ms v3 (knowledge base v3.0).On vitek 2 (v7.01) gp cards, one (1) card of the customer lot (cl1 : 2420434403), one (1) card of the customer lot (cl2 : 2420330113) and one (1) card of a random lot (rl : 2420490403) were tested from cba subculture.All three (3) card lots gave an excellent identification to e.Faecalis.The customer misidentification was not duplicated in-house.The vitek 2 gp card performed as intended.No further action is required.

• Brand Name: VITEK® 2 GRAM POSITIVE TEST KIT
• Type of Device: VITEK® 2 GP TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; saint louis, MO 63042
• MDR Report Key: 6993283
• MDR Text Key: 91466630
• Report Number: 1950204-2017-00359
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: C1 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: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420330113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2017
• 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