MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM NEGATIVE ID TEST KIT

Catalog Number 21341

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer notified biomerieux that they had mis-identifications when using the vitek® 2 gram negative id test kit.A pseudomonas sample was identified by the test kit as a burkholderia.Additionally, an acinetobacter was as klebsiella oxytoca.When specifically asked the customer noted no injury or death happened as a result of the mis-identifications.An investigation will be initiated by biomerieux to investigate this event.

Manufacturer Narrative

This report was initially submitted following notification that a customer in canada reported occasional misidentification of gram negative rods (e.G.Pseudomonas as burkholderia or acinetobacter as klebsiella) in association with the vitek® 2 gn id test kit.Biomérieux investigation was conducted.However, no patient strains, lab reports, raw data, lot # nor software version were provided by the customer.The customer reported testing the isolates from bbl chrom agar which is a non-recommended media.Testing from a non-recommended media may cause atypical reactions according to the vitek® 2 gn id knowledge base.A complaint history review was completed for these issues during the last 13 month timeframe with no implication of a trend.The most recent quarterly trend review did not identify this complaint as a systemic quality issue.Without the patient isolate(s) or raw data, no further investigational testing is possible.There is no evidence to suggest the vitek® 2 gn id test kit is performing outside of specifications.

• Brand Name: VITEK® 2 GRAM NEGATIVE ID TEST KIT
• Type of Device: VITEK® 2 GRAM NEGATIVE ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 5846485
• MDR Text Key: 52417200
• Report Number: 1950204-2016-00081
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: CL. I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2016
• Device Catalogue Number: 21341
• Device Lot Number: 241354540
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1