MAUDE Adverse Event Report: BIOMERIEUX 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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) contacted biomerieux to report a misidentification of streptococcus equi ssp equi as streptococcus equi ssp zooepidemicus in association with the vitek® 2 gram-positive (gp) identification (id) test kit.The customer stated the isolate was obtained via abscess swab from a horse.The customer indicated the vitek 2 result was not used in the treatment decisions for the patient.Therefore, there was no adverse impact to the patient (a horse) as a result of vitek 2 testing.Biomérieux requested strain submittal from the customer.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

An internal biomérieux investigation was initiated due to a misidentification of one strain of streptococcus equi ssp equi (confirmed by customer by a pcr method) as streptoccus equi ssp zooepidemicus on vitek® 2 v8.02, using vitek 2 gp id cards.The customer submitted the strain for the investigation.The intended identification was confirmed on vitek ms v3 (knowledge base v3.2) to streptococcus equi ssp equi (99.9%).On vitek 2 (v8.02) gp cards, one (1) card of the customer lot (cl : 2420603403) and one (1) card of a random lot (rl : 2420758203) were tested from cba subculture under co2 atmosphere.These tests gave an excellent identification to streptococcus equi ssp equi (99%) with both lots tested.Four (4) atypical reactions were observed on the customer's results and were not reproduced in-house.This could explain the customer misidentification.An increased number of atypical reactions can indicate contamination, mixed culture, use of non-recommended media, user set up error, or an atypical strain.The customer misidentification to streptococcus equi ssp zooepidemicus is not reproduced in-house whatever the lot tested.The vitek 2 gp id card performed as intended, and no further action is required.

• Brand Name: VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT
• Type of Device: VITEK® 2 GP ID CARD
• 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: jeff scanlan ; 595 anglum road; hazelwood, MO 63042 ; 3147318694
• MDR Report Key: 7601573
• MDR Text Key: 112150210
• Report Number: 1950204-2018-00225
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 10/22/2018

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: 07/22/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420603403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/14/2018
• Supplement Dates Manufacturer Received: 09/25/2018
• Supplement Dates FDA Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2018
• 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