MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VITEK 2 AST-N387 TEST KIT

Catalog Number 423313

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of sample filling issues that lead to antibiotic terminations and card terminations for multiple patient urine samples (organism species not provided by customer) in association with the vitek® 2 ast-n387 test kit (ref.423313, lot 0371549404).Retesting of the isolates with the ast-n387 card obtained the same results, terminated antibiotics with the message "initial value too low for analysis and insufficient growth in the pc well".The customer noted that for some of the samples a filling issue was observed.The customer said that they are noticing that different systems (vitek® 2 and vitek® 2 compact) show this error but only for this impacted card and lot.The customer used alternate methods to obtain the ast results (vitek® 2 ast-n233 test kit and a different lot of vitek® 2 ast-n387 test kit).No terminations were observed.The customer stated visual inspection of the cards prior to use showed no evidence of card issues/damage.The customer stated a total of eighty-five (85) patient isolates were tested; some isolates had a delay of greater than twenty-four (24) hours in reporting results due to the filling issues.The total number of patient isolates which had a delay of greater than 24 hours was not provided.There is no indication or report from the customer that the delay resulted in any adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

This investigation was initiated in response to a complaint from a customer site in germany.The customer observed card and drug terminations (trms) with multiple isolates over the course of multiple days when using ast-n387 lot 0371549404.Trms were not observed for other lots during the same time period.The complaint indicated that the customer examined impacted cards and noted filling issues.Review of cards returned by the customer indicated that the cards with fill issues were caused by top tape placement shifting away from the top rail of the card.This caused the inlet port window to not be fully enclosed, preventing the inoculum from being taken into the card when loading on the vitek® 2 instrument.The investigation revealed that there was a robot fault around the time the impacted cards were top-taped.This would have required cards to be placed into the up-stacker manually and it is most likely that cards were loaded into the equipment incorrectly.The vision system rejected the incorrectly loaded cards as expected.However, cards with top tape placement issues were inadvertently re-introduced into the lot as a result of a failure to identify the defective material during re-inspection of the vision system rejects.Customer returns and device history record (dhr) review indicates that the issue was corrected during manufacturing of ast-n387 lot 0371549404.Customers are instructed to check saline levels after filling to ensure the cards fill properly and to eject or not load any cards that do not fill properly.Root cause: cards were loaded incorrectly into the taping equipment which caused the misplaced tape and failure of the technician to identify the cards with misaligned tape.Conclusion: multiple corrective/preventive actions were identified.Workmanship standards will be updated to assist the technician in identification of the defective cards.Multiple procedures will be updated to ensure proper loading of cards.Additionally, an ongoing project will be implemented for new equipment designs to further reduce the likelihood of cards produced with misaligned tape.

• Brand Name: VITEK 2 AST-N387 TEST KIT
• Type of Device: VITEK 2 AST-N387 TEST KIT
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 10954077
• MDR Text Key: 225594966
• Report Number: 1950204-2020-00210
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

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: 02/22/2022
• Device Catalogue Number: 423313
• Device Lot Number: 0371549404
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 12/05/2020
• Supplement Dates Manufacturer Received: 05/12/2021
• Supplement Dates FDA Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1