MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT FA PLUS; BACT/ALERT® FA PLUS

Catalog Number 410851

Device Problem Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of contamination with paenibacillus provecensis in association with the bact/alert® fa plus (plastic) culture bottle (ref.410851) when testing blood culture.The customer has not specified the impacted fa plus culture bottle lot.Biomérieux has requested further information regarding the specific lot of bact/alert® fa plus (plastic) culture bottle, number of patients involved, as well as if the bottles were inspected for contamination prior to inoculation.There is no indication or report from the laboratory that the contamination result led to any adverse event related to any patient's state of health.Biomérieux has initiated an internal investigation.

Manufacturer Narrative

This report was initially submitted following notification from a customer in spain regarding contamination with paenibacillus provecensis in association with the bact/alert® fa plus (plastic) culture bottle (ref.410851) when testing blood culture.The customer did not specify the impacted fa plus culture bottle lot at the time of the complaint.Biomerieux had requested further information regarding the specific lot of bact/alert® fa plus (plastic) culture bottle.During the investigation, the bottle lot was obtained by photos provided by the customer.The impacted bact/alert® fa plus (plastic) culture bottle was from lot 0004055540.Based on the evaluation of data and limited information provided by the customer, the most probable root cause for contamination of the bottle from bact/alert® fa plus culture bottle with paenibacillus provecensis is human error (bottle handling) by the customer.Bact/alert® fa plus culture bottle instructions for use (ifu) state prior to inoculation, the culture bottle top needs to be disinfected with an alcohol swab or equivalent and allowed to dry.The contaminant (paenibacillus provecensis) found in the bact/alert® fa plus culture bottle at the customer site is a gram positive spore-forming rod, primarily found in the environment and is known to be a common blood culture contaminant, per published literature.Use of one disinfectant prep per bottle top aids in the removal of spores which are resistant to disinfectants.The mechanical wiping action of the disinfectant prep picks the spores up off the bottle stopper.In addition, care must be taken to prevent contamination of a venipuncture during inoculation into the culture bottles (e.G.Proper skin disinfection).Cumitech 1c 4 for the proper specimen collection techniques (referenced in the instructions for use) stresses that the disinfection of the venipuncture site is very important in order to reduce contamination.Contamination could lead to a specimen being determined positive when a clinically relevant isolate is not actually present.This situation occurred with the customer¿s samples resulting in false positives by the contaminant of paenibacillus provecensis.There is no evidence of any bottle malfunction with the bact/alert® fa plus culture bottle lot.Monitoring and detection methods for potential bottle contamination are part of the manufacturing and quality control processes for bact/alert® culture bottles.The quality control bioburden results for bact/alert® fa plus lot 0004055540 were within the cfu/ml final release specifications.There is no indication that the manufacturing process of bact/alert® fa plus lot 0004055540 culture bottles contributed to the contamination issue.

• Brand Name: BACT/ALERT FA PLUS
• Type of Device: BACT/ALERT® FA PLUS
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• MDR Report Key: 10730573
• MDR Text Key: 231687747
• Report Number: 3002769706-2020-00015
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026357900
• UDI-Public: 03573026357900
• Combination Product (y/n): N
• PMA/PMN Number: K121461
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 410851
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1