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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from (b)(6) notified biomérieux of misidentification results when testing a streptococcus equi ssp zooepidemicus isolate obtained from an equine nasal swab.The testing and results were as follows: vitek 2 result : streptococcus equi ssp equi.Api result - streptococcus equi ssp zooepidemicus.Pcr result - streptococcus equi ssp zooepidemicus.The customer reported that no results were affected, no wrong result was reported, and no animal was harmed or treated incorrectly.The results were delayed by four days.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed due to a misidentification of a streptococcus equi ssp zooepidemicus strain as streptococcus equi ssp equi on vitek ® 2 v8.02 gp cards.The 16s sequencing result gave an identification to streptococcus equi ssp zooepidemicus.On vitek 2 (v8.02) gp cards, one card of the customer lot (cl : 2420654403) and one card of a random lot (rl : 2420758203) were tested from cba subculture under co2 atmosphere.These tests gave an excellent identification to streptococcus equi ssp zooepidemicus (99% for cl and 97% for rl) with both lots tested.The customer misidentification to streptococcus equi ssp equi is not reproduced in-house whatever the lot tested.The customer profile has several discrepant reactions (aspa+, proa+, baci-, o129r-, adh2s-) compared to internal results.The vitek 2 gp card performed as intended and no further action is required.

• 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; saint louis MO 63042
• MDR Report Key: 7824958
• Report Number: 1950204-2018-00302
• Device Sequence Number: 13775741
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 11/02/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420654403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1