MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 GN ID TEST KIT

Catalog Number	21341
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 in (b)(6) reported discrepant identification results in association with the vitek® 2 gn id test kit and vitek 2 systems software 8.01.The customer reported that an isolate was identified as shigella sonnei (99.9%) with vitek, and escherichia coli (94%) with api® 20e.The customer then ran pcr (bd max) and obtained shiga toxin.The specimen was then sent to a reference lab.The result of shiga toxin was reported to the clinician.The customer did not know if patient treatment was impacted.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was initiated due to a customer reported misidentification of escherichia coli o157 as shigella sonnei when tested in the vitek® 2 gn card, lot 32410597403, and using vitek 2 software version 8.01.The strain was identified as e.Coli by api and positive for shiga toxin by bd max pcr.The customer strain and raw data are not available.Investigation: the customer reported setting up the strain from xld agar using a 0.5 mcfarland.No other set up information as provided.The customer also reported cleaning their dispensette with alcohol.Cleaning the dispensette with alcohol or other chemical agents is not recommended as it may cause atypical reactions.One lab report was submitted showing an excellent identification of s.Sonnei with two atypical positive reactions (5kg, bgur) for an identification of e.Coli o157 according to the gn knowledge base.It appears that the customer based the identification of e.Coli o157 from the api result (e.Coli) and the presence of shiga toxin (from pcr).However, it should also be noted that while it is not common for s.Sonnei to produce shiga toxin, there have been cases reported that s.Sonnei has produced shiga toxin 1 (emerg infect dis.2016 apr; 22(4): 679-686).Atypical positive reactions can indicate contamination, mixed culture, use of non recommended media or other user set up errors (including cleaning the dispensette with alcohol) or an atypical strain.However, without the strain or raw data it's not possible to further evaluate the cause of the misidentification.The vitek 2 gn id card lot# 2410597403 met final qc release criteria.This lot passed qc performance testing.

• Brand Name: VITEK® 2 GN ID TEST KIT
• Common Device Name: VITEK® 2 GN ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 8048673
• Report Number: 1950204-2018-00476
• Device Sequence Number: 1586080
• Product Code: LQM
• UDI-Device Identifier: 03573026131913
• UDI-Public: 03573026131913
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2019

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: 07/16/2019
• Device Catalogue Number: 21341
• Device Lot Number: 2410597403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1