MAUDE Adverse Event Report: VITEK® 2 GRAM-POSITIVE (GP) TEST KIT

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 the united states notified biomérieux of a misidentification with the vitek 2 gram-positive (gp) test kit vtk2 20 cards (b)(4).A customer reports that the vitek 2 identified an organism as group b strep with a 96% confidence level; however, the organism was reported by the customer as not looking like group b step on media.The customer reports that a positive blood culture was run on nanosphere and identified as a strep species; in addition, a bd/bbl streptocard latex test identified the organism and a group g strep.The customer reports that the incorrect identification was reported to the physician; however, the physician did not report patient harm or incorrect treatment as the treatment would have been the same regardless.An internal biomerieux investigation will be initiated.

• Brand Name: VITEK® 2 GRAM-POSITIVE (GP) TEST KIT
• Type of Device: VITEK® 2 GRAM-POSITIVE (GP) TEST KIT
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 5808567
• MDR Text Key: 50124891
• Report Number: 1950204-2016-00074
• 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: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Catalogue Number: 21342
• Device Lot Number: 242391010
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1