MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK 2 AST-N226 TEST KIT; VITEK® 2 AST-N226 TEST KIT

Catalog Number 413143

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A biomérieux internal investigation was initiated in response to this customer complaint.The customer's isolate was submitted for investigational testing.The identification of the organism was confirmed to be escherichia coli by vitek® ms testing.Investigational testing consisted of testing the customer's sample with retain samples of ast-n266 cards from the customer's lot (6260985403) and a random lot (6260881203) as well as broth microdilution (bmd) testing as a reference method for imipenem.For both ast-n266 card lots tested, susceptible imipenem results were obtained.The susceptible results correlated to the mics obtained using the reference bmd method.The customer's resistant results were not reproduced in house and the cards are performing as intended.A complaint search for the implicated lot did not identify trends for complaints against the lot.Ast-n226 lot #(6260985403) met final qc release criteria.The lot passed qc performance testing.

Event Description

A customer in (b)(6) notified biomérieux of a false resistant imipenem result for an escherichia coli patient isolate in association with the vitek® 2 ast-n226 test kit (ref 413143, lot 6260985403).Repeat testing using the same lot of ast-n226 card obtained susceptible results.Disk diffusion (kirby-bauer) testing also obtained susceptible results.The customer communicated that there was a delay in reporting results of 24 hours, but no incorrect results were reported and there was no negative impact to patient health or treatment due to the initial discrepant results.A biomérieux internal investigation was initiated in response to this customer complaint.During a retrospective review of vitek 2 mdr submissions it was determined that this imipenem malfunction was not reported to fda.The associated complaint was received by biomerieux on 10 jul 2019 and was assessed for reportability within thirty days.Mdr 1950204-2019-00245 was submitted to fda on 01 aug 2019 for a meropenem malfunction reported in the same complaint.Biomerieux apologizes for the mdr omission and we wish to ensure full transparency of reportable events, hence we are submitting this mdr.There was no patient injury associated with this malfunction.

• Brand Name: VITEK 2 AST-N226 TEST KIT
• Type of Device: VITEK® 2 AST-N226 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 11098635
• MDR Text Key: 238386771
• Report Number: 1950204-2020-00222
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K183415
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2020
• Device Catalogue Number: 413143
• Device Lot Number: 6260985403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1