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 biomerieux of contamination with bacillus licheniformis in association with the bact/alert® fa plus culture bottle (ref.410851, lot 0004055630) while testing patient blood cultures.The customer confirmed the two (2) patients were from separate hospital wards.Blood collection for both patients was performed on the same day using the bact/alert® fa plus culture bottle lot 0004055630 and 0004055274 as well as the bact/alert® fn plus culture bottle lot 0004055368.Biomerieux asked the customer if lot 0004055630 was used for testing with both patients or a single patient; however, no response has been provided.All bottles were positive for growth and subcultured.The isolates were identified as bacillus licheniformis using the mass spectrometry test method.The bacillus licheniformis identifications were reported to the treating physician; however, 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.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in france regarding contamination with bacillus licheniformis in association with the bact/alert® fa plus culture bottle (ref.(b)(6), lot 0004055630) while testing patient blood culture.This organism is known to be a common blood culture contaminant, per published literature.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 lot 0004055630 is human error (bottle handling) by the customer.The customer is provided with instructions in the instructions for use (ifu) that address how to reduce the chance of contamination during sample collection/bottle inoculation into fa plus bottles.The ifu also reference cumitech 1c 4 for the proper specimen collection techniques.This document stresses the disinfection of the venipuncture site is very important in order to reduce contamination (e.G.Vigorously cleansing), and that contamination could lead to a specimen being determined positive when a clinically relevant isolate is not actually present.Approximately one hundred (100) culture bottles from fa plus lot 0004055630 retain stock were tested for potential contamination in response to this complaint issue of bacillus licheniformis.All time to detection (ttd) for the retain bottles resulted in negative to date status after incubation of approximately 4.1 days.Negative to date is defined as no presence of microbial growth in the culture bottle after a specified time period.A review of reflectance graphs showed flat lines with no increase in reflectance units, indicative of no microbial growth.No adverse trends relating to potential bottle contamination issues from the manufacturing data of bact/alert® fa plus lot 0004055630, nor complaint trends related to bacillus licheniformis were found.There is no evidence of any bottle malfunction with the bact/alert® fa plus culture bottle lot 0004055630, nor indication that the manufacturing process contributed to the contamination issue as per the complaint by the customer.Monitoring and detection methods for potential bottle contamination are part of the manufacturing and quality control processes for bact/alert® culture bottles.The lot met all quality control and release specifications.See section h10.

• 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: 10864020
• MDR Text Key: 247891506
• Report Number: 3002769706-2020-00017
• 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: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2021
• Device Catalogue Number: 410851
• Device Lot Number: 0004055630
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1