MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 GRAM NEGATIVE IDENTIFICATION TEST KIT; 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 Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the (b)(6) notified biomérieux of misidentification results for a providencia stuartii eqa strain when testing with the vitek® 2 gn id test kit (ref 21341).The gn card provided an identification of aeromonas salmonicida.The strain was retested using bruker maldi-tof and identified as providencia stuartii.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was initiated due to a customer report of the misidentification of providencia stuartii as aeromonas salmonicida when testing with the vitek® 2 gn card lot # 2410348203 and using vitek 2 software version 8.01.The strain was from an eqa survey and identified by maldi (bruker).Strain and raw data are not available.Investigation: the customer reported setting up the strain from columbia blood agar that incubated for 20+/-2 hrs at 37c.Mcfarland was prepared within range and saline was sterile.The last pm of the system had been performed in (b)(6) 2018 and was not due until (b)(6) 2019; however, a pm was performed on the system at the time of the complaint investigation, and all issues were resolved.One lab report was submitted showing a very good identification of a.Salmonicda with only one positive reaction.In addition there were 14 atypical negative reactions (proa, o129r, bnag, dtre, suct, dglu, dmne, tyra, cit, naga, ellm, ggt, off, phos) for an identification of p.Stuartii according to the gn knowledge base.Atypical negative reactions can indicate a strain with decreased viability, user set up error or an atypical strain.Since the issue corrected upon pm of the instrument, it appears that the instrument contributed to the misidentification.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# 2410348203 met final qc release criteria.This lot passed qc performance testing.

• Brand Name: VITEK® 2 GRAM NEGATIVE IDENTIFICATION TEST KIT
• Common Device Name: VITEK® 2 GN ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• MDR Report Key: 7982299
• Report Number: 1950204-2018-00436
• Device Sequence Number: 1302536
• Product Code: LQM
• UDI-Device Identifier: 03573026131913
• UDI-Public: 03573026131913
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 01/03/2019

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: 11/09/2018
• Device Catalogue Number: 21341
• Device Lot Number: 2410348203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1