MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK 2 GRAM-POSITIVE IDENTIFICATION TEST KIT; VITEK 2 GP ID CARD

Catalog Number 21342

Device Problems Fluid/Blood Leak (1250); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Bacterial Infection (1735); Exposure to Body Fluids (1745); Eye Injury (1845); Intraocular Infection (1933); Test Result (2695)

Event Date 05/05/2015

Event Type  Injury  

Event Description

A customer in the united states reported an inoculum splash of a sample suspension containing staphylococcus capitis.The splash occurred while vortexing the sample in a greiner bioone test tube for identification (id) testing via vitek® 2 gram-positive identification (gp id) test kit.The laboratory technician states he lost his grip on the tube, the tube hit the counter, and splashed some of the contents in his eye.The technician was not wearing eye protection (goggles, glasses, face shield) nor using tube caps to prevent spillage.The technician visited the hospital emergency room and was treated with augmentin for a pre-existing sinus infection and was prescribed gentamycin eye drops for his eye.The technician claims no eye issues prior to the inoculum splash.The technician made a full recovery; no additional treatment or testing was required.The technician's eye culture returned an organism id of coagulase negative staphylococcus; the nasal culture was staphyloccocus aureus.An internal investigation is in progress.

Manufacturer Narrative

No device returned to manufacturer.

Manufacturer Narrative

Biomérieux investigation was conducted.Sample: staphylococcus (staph) capitis.Technician's eye culture: coagulase negative staph (technician also had existing staph aureus sinus infection).Based on the manual of clinical microbiology, 10th edition: staph capitis is found surrounding the sebaceous glands on the forehead and scalp following puberty.It is a coagulase negative staph.No testing of the patient isolate was performed as the reported event did not claim incorrect results from use of the vitek® 2 systems.There was no challenge regarding vitek® 2 gp test kit performance.Biomérieux, inc.Customer support provided recommendations to the customer regarding precautions to implement when vortexing (use of splash shield, hood, or safety glasses).Refer to good laboratory practices.The biomérieux, inc.Product information contains the following information: red warning message stating that "all patient specimens and microbial cultures are potentially infectious, and should be handled with universal precautions." note under set-up - "prepare inoculum from pure culture according to good laboratory practices.".

• Brand Name: VITEK 2 GRAM-POSITIVE IDENTIFICATION 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: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 4928605
• MDR Text Key: 6015238
• Report Number: 1950204-2015-00015
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2016
• Device Catalogue Number: 21342
• Device Lot Number: 242352510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2015
• 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
• Patient Outcome(s): Required Intervention