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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) contacted biomerieux to report a misidentification of streptococcus dysgalactiae as streptococcus pseudoporcinus in association with the vitek® 2 gram-positive (gp) identification (id) test kit.The customer stated the isolate was obtained from a milk sample.Milk source not provided; however, this customer is a veterinary site.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to the patient's (animal) state of health.Biomérieux requested strain submittal from the customer.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

This report was initially submitted following notification by a customer in (b)(6)contacted biomerieux of a misidentification of streptococcus dysgalactiae as streptococcus pseudoporcinus in association with the vitek® 2 gram-positive (gp) identification (id) test kit.The customer stated the isolate was obtained from a milk sample.Milk source not provided; however, this customer is a veterinary site.Vitek 2 systems software version 8.02 is in use at the customer site.Biomérieux internal investigation was conducted using the strain submitted by the customer.The strain was subcultured on cba medium under co2 atmosphere.Testing included: - sequencing (gene soda) to confirm the intented result; the strain was identified to streptococcus dysgalactiae ssp dysgalactiae (99%) (assay 034 lbmsc-id).- vitek 2 gp id card (customer lot and random lot) obtained low discrimination between streptococcus dysgalactiae ssp equisimilis and streptococcus dysgalactiae ssp dysgalactiae with both lots tested.- vitek ms v3 (knowledge base v3.2) obtained organism identification to the species streptococcus dysgalactiae, but no distinction between the two subspecies s.Dysgalactiae ssp dysgalactiae and s.Dysgalactiae ssp equisimilis.The misidentification to streptococcus pseudoporcinus is not reproduced in-house.The investigation concluded the vitek 2 gp id card performs as intended.

• 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: 7601558
• MDR Text Key: 112152023
• Report Number: 1950204-2018-00226
• 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: 10/29/2018

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: 10/01/2018
• Supplement Dates FDA Received: 10/29/2018
• 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