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

Catalog Number	21342
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Misdiagnosis (2159); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from (b)(6) reported a misidentification of actinomyces israelii as gardnerella vaginalis in association with the vitek® 2 gp id test kit.The customer stated they cultured a gram-positive rod from pleural fluid which was identified with vitek 2 gp id card as gardnella vaginalis.The isolate was tested multiple times on vitek ms and the results were no identification.The sample was sent to the public health england at colindale who identified the isolate as actinomyces israelii by partial sequencing of the 16s rrna gene.The customer reported that the patient was given inappropriate antimicrobial treatment prior to the correct identification of actinomyces israelii, which was obtained 10 days later from the reference lab.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
(b)(4).
Additional Manufacturer Narrative
An internal biomérieux investigation was initiated for a customer in (b)(6) who reported a misidentification of actinomyces israelii as gardnerella vaginalis when tested in the vitek® 2 gp id card.The strain was identified as actinomyces israelii by partial sequencing of the 16s rrna gene.Strain, lab reports, raw data, lot number, and software version were not available.Actinomyces israelii is not a claimed species for the vitek 2 gp knowledge base.When an isolate is tested in the vitek 2 gp id card, it will attempt to match the reactions to known reaction patterns stored in the knowledge base.If the reaction pattern of an unclaimed species is tested and match those in the knowledge base with a high degree of confidence, a misidentification can occur.The vitek 2 product instructions for use (ifu) contain the following warning in the limitations section: testing of unclaimed species may result in an unidentified result or a misidentification.The vitek 2 anc id card would be the appropriate identification card for this species.

• Brand Name: VITEK® 2 GP ID TEST KIT
• Common Device Name: VITEK® 2 GP ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 7885777
• Report Number: 1950204-2018-00371
• Device Sequence Number: 13499115
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 21342
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 08/23/2018; 11/09/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 09/19/2018; 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other