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

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) reported misidentifications of five (5) (b)(6) strains as (b)(6) in association with the vitek® 2 gp test kit.The five (5) isolates were from blood and wound cultures from one patient.The customer reported the gp card identified (b)(6), and the coagulase was (b)(6).The customer stated that two reference labs identified the strains as (b)(6) and one lab used the maldi-tof method.No patient information was provided by the customer.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) reported misidentifications of five (5) staphylococcus aureus strains for one patient in association with the vitek® 2 gp test kit.The customer reported the gp card identified staphylococcus lugdonensis, and the coagulase was positive.The customer stated that two reference labs identified the strains as (b)(6) and one lab used the maldi-tof method.Strains, lab reports, raw data and software version not available for this investigation.No information regarding set up was provided by the customer.Strains, lab reports or raw data were not provided so it's not possible to further evaluate the cause of the misidentifications.Vitek 2 gp lot # 2420575103 met final qc release criteria.This lot passed qc performance testing.

• Brand Name: VITEK® 2 GP TEST KIT
• Type of Device: VITEK® 2 GP TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: debra broyles ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 7851237
• MDR Text Key: 120252166
• Report Number: 1950204-2018-00336
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 2420575103
• UDI-Public: 2420575103
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420575103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 09/06/2018
• Supplement Dates Manufacturer Received: 10/25/2018
• Supplement Dates FDA Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2017
• 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