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
An internal publication review of the article "klebsiella grimontii, a new species acquired carbapenem resistance," by lu liu, yu feng, yiyi hu, mei kang, yi xie, and zhiyong zong, noted the misidentification of the newly identified klebsiella grimontii species as klebsiella oxytoca when testing with the vitek® 2 gn id test kit.It should be noted that this new species is not claimed in the vitek 2 gn id knowledge base.As there is no patient associated with this journal article study, there is no adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
The publication "klebsiella grimontii, a new species acquired carbapenem resistance," by lu liu, yu feng, yiyi hu, mei kang, yi xie, and zhiyong zong, noted the misidentification of the newly identified klebsiella grimontii species as klebsiella oxytoca when testing with the vitek® 2 gn id test kit.Klebsiella grimontii is a newly identified species closely related to klebsiella oxytoca.The strain identification klebsiella grimontii was confirmed by genome sequencing.The strains, lab reports, troubleshooting description and the gn lot number are not available.Without this information, it is not possible to evaluate the misidentification.Klebsiella grimontii is not a claimed in the vitek 2 gn id knowledge base.Per the ifu, testing of unclaimed species may result in a misidentification or unidentified result.Since vitek 2 gn id test kit lot number used was not given, a qc review against the lot in question could not be performed.

• 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: 8261583
• Report Number: 1950204-2019-00026
• Device Sequence Number: 16697003
• Product Code: LQM
• UDI-Device Identifier: 03573026131913
• UDI-Public: 03573026131913
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature,study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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: Other
• Device Catalogue Number: 21341
• 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: 03/05/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1