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  

Event Description

A customer reported to biomerieux an incident that a vitek 2 gram positive (gp) identification (id) test kit obtained a discrepant organism identification.Aerococcus viridans was misidentified as leuconostoc on a quality control sample.There is no indication from the hospital or treating physician to biomerieux that the discrepant result led to any adverse event related to any patient's state of health.An investigation into this incident has been initiated within biomerieux.

Manufacturer Narrative

This report was initially submitted following notification that a customer in (b)(6) reported a misidentification on vitek® 2 gp id for an external quality control sample (ctcb 1531) intended aerococcus viridans but identified as leuconostoc spp.Biomérieux investigation was conducted.Tests performed: vitek® ms.Rapid id 32strep.Api20strep.Vitek® 2 gp id (customer lot 242362410 and a random lot 242354910).Results: vitek® ms: identification to aerococcus viridans 99.9%.Rapid id32strep: identification to aerococcus viridans 98.5%.Api 20strep: identification to aerococcus viridans 99.3%.Vitek® 2 gp id: identification to aerococcus viridans on the 2 lots tested.The investigation did not duplicate the misidentification observed by the customer.The investigation confirmed the identification to the species aerococcus viridans with all methods tested, including vitek® 2 gp id.The vitek® 2 gp id cards are performing in accordance with specifications.

• 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: 5255264
• MDR Text Key: 32323618
• Report Number: 1950204-2015-00110
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K952095
• 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: 11/19/2015

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: 11/15/2016
• Device Catalogue Number: 21342
• Device Lot Number: 242362410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2015
• Initial Date FDA Received: 11/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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