MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 GRAM POSITIVE ID TEST KIT; VITEK® 2 GP ID TEST KIT

Catalog Number	21342
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A veterinary customer from the (b)(6) notified biomérieux of a misidentification result for streptococcus equi ssp zooepidemicus atcc strain 700400 when testing with the vitek® 2 gp id test kit (ref (b)(4), lot 2420595103).The vitek 2 gp id card obtained an identification of streptococcus canis.An internal biomérieux investigation has been initiated.
Additional Manufacturer Narrative
An internal investigation was performed for a veterinary customer from the (b)(6) reporting a misidentification result for streptococcus equi ssp zooepidemicus atcc strain 700400, as streptococcus canis when testing with the vitek® 2 gp id test kit (ref 21342, lot 2420640403).The investigation was initiated due to a misidentification of three strains of streptococcus equi ssp species identified as s.Canis on vitek 2 v8.02, gp cards.The customers submitted the strains and sequencing (gene soda) results confirmed the identification to streptococcus equi ssp zooepidemicus.On vitek 2 (v8.02) gp cards, one card of the customer lot (cl1 : 2420640403), one card of the customer lot (cl2: 2420595103) and one card of a random lot (rl: 2420822203) were tested from cos subculture under co2 atmosphere with the three strains.These tests gave: s1 : excellent identification to streptococcus equi ssp zooepidemicus whatever the lots tested.S2 : excellent identification to streptococcus equi ssp zooepidemicus whatever the lots tested.S3 : low discrimination between streptococcus agalactiae / streptococcus equi ssp equi / streptococcus equi ssp zooepidemicus on cl1 and low discrimination between streptococcus canis / streptococcus equi ssp zooepidemicus on cl2 and rl.Alternative method vitek ms v3 (knowledge base v3.2) no distinction between streptococcus equi ssp ruminatorum and streptococcus equi ssp zooepidemicus.The customer misidentification was not reproduced in-house.The most recent quality systems quarterly trend review (q2 2018) did not reveal this issue as a trend.A complaint search against gp card lots 2420640403 and 2420595103 did not indicate any issues for these lots.

• Brand Name: VITEK® 2 GRAM POSITIVE ID TEST KIT
• Common Device Name: VITEK® 2 GP ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 7903666
• Report Number: 1950204-2018-00391
• Device Sequence Number: 19180953
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420595103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1