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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biomérieux of misidentification results when testing with the vitek® 2 gn id test kit (ref 21341).A patient strain was identified as providencia rustigianii using the vitek 2 gn card, lot: 2410578203, with initial and repeat testing.When the customer performed the identification with api, it identified the strain as providencia stuartii.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was initiated due to a misidentification of providencia stuartii as providencia rustigianii associated with the vitek® 2 gn card lot# 2410578203 and using vitek 2 software version 8.01.The isolate was identified as p.Stuartii when tested with api® 20e.Strain and raw data were indicated as not being available.In addition, no set up information was provided by the customer.Two (2) vitek 2 gn id lab reports were submitted.Both showed a very good identification of p.Rustigianii with one (1) atypical negative reaction (bnag) 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.Without the strain or raw data, it's not possible to further evaluate the cause of the misidentification.Vitek 2 gn card lot # 2410578203 met final qc release criteria and passed qc performance testing.No additional action related to this issue was deemed necessary per quality review.---correction--- mfr report # has been corrected to 1950204-2018-00435 after a request was received from fda on 11may2023.The contents of this report were initially submitted with the incorrect mfr report # (1950204-2180-00435) on 26dec2018.

• 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
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• Manufacturer Contact: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 7974209
• Report Number: 1950204-2018-00435
• Device Sequence Number: 19136267
• Product Code: LQM
• UDI-Device Identifier: 03573026131913
• UDI-Public: 03573026131913
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2023

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: 06/27/2019
• Device Catalogue Number: 21341
• Device Lot Number: 2410578203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown