MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM-POSITIVE IDENTIFICATION 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  

Manufacturer Narrative

Biomérieux investigation has been conducted.Investigational testing of the isolate included.Vitek® 2 gp id (customer lot and random lot, two cards each): all four gp id cards tested resulted in excellent identifications of enterococcus faecium.Api® 20 strep: resulted in excellent identifications of enterococcus faecium.The investigation concluded the vitek® 2 gp id test kit is performing as intended.

Event Description

A customer in the united states contacted biomérieux to report a misidentification of a patient isolate (enterococcus faecalis) as enterococcus gallinarum in association with the vitek® 2 gram-positive (gp) identification (id) test kit.Upon identification of the patient isolate as enterococcus gallinarum, the customer sent the isolate to arup for confirmatory testing.Testing by arup via maldi-tof obtained an organism identification of enterococcus faecalis.The customer indicated no patient harm or injury occurred as a result of the organism identification discrepancy.Culture submittal was requested from the customer for bioméreiux investigation testing.

• 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: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6348763
• MDR Text Key: 67946903
• Report Number: 1950204-2017-00061
• 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 faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420063403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2016
• 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