MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT; VITEK® 2 GP ID CARD

Catalog Number 21342

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 contacted biomérieux to report the occurrence of misidentification of streptococcus constellatus (cap survey strain2017 d-17) as streptococcus anginosus in association with the vitek® 2 gp id test kit.Upon notification from cap, the customer repeated the test; obtained a low discrimination identification strep.Anginosus / strep.Constellatus ssp constellatus / strep.Gordonii.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.There was no patient directly associated with the cap survey strain.Biomérieux investigation has been initiated.

Manufacturer Narrative

This report was initially submitted in response to a customer in the united states notifying biomérieux of misidentification results for streptococcus constellatus (cap survey strain2017 d-17) as streptococcus anginosus in association with the vitek® 2 gp id test kit.Upon notification from cap, the customer repeated the test; obtained a low discrimination identification strep.Anginosus / strep.Constellatus ssp constellatus / strep.Gordonii.An internal biomérieux investigation was performed.The biomérieux internal cap d-17 swab was re-hydrated and subcultured to remel tsab agar.Testing included individual organism suspensions with vitek 2 gp cards from three (3) different card lots as well as the vitek ms.The gp cards resulted in excellent identification of s.Constellatus on one card, and low discrimination s.Constellatus / s, agalactiae on five cards.The vitek ms confirmed the isolate as s.Constellatus with a 99.9% confidence value.The vitek 2 gp cards performed as expected.

• Brand Name: VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT
• Type of Device: VITEK® 2 GP ID CARD
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 7448263
• MDR Text Key: 106861972
• Report Number: 1950204-2018-00154
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CL. I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420488103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2017
• 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