MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT® SN CULTURE BOTTLE

Catalog Number 259790

Device Problem Contamination (1120)

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

Event Date 09/29/2017

Event Type  malfunction  

Event Description

A customer from the united states notified biomérieux of contamination associated with bact/alert® sn bottles (reference 259790).The customer reported having three (3) possible contaminates of bacillus.Patient #1 - the sample comes from a children's hospital, (b)(6).Patient #1 - (b)(4).Date collected - (b)(6) 2017 at 10:40am.Date loaded - (b)(6) 2017 at 13:15.Received - (b)(6) 2017 at 11:00am.Flagged positive at the 3d - (b)(6) 2017 at 16:10.Isolate displayed growth from media plates on: (b)(6) 2017.Patient #2 - the patient is a (b)(6).The sample was collected from an in-house floor.It appears the patient has issues with his liver (but no specific diagnosis).The in-house floor is called the solid organ transplant floor patient #2 - (b)(4).Date collected - (b)(6) 2017 at 17:46.Date received - (b)(6) 2017.Flagged positive at the 3d - (b)(6) 2017 at 06:53.Isolate displayed growth from media plates on: (b)(6) 2017.Patient #3 - the patient s sample was collected at the cancer center.The patient is an elderly woman (b)(6).Patient #3 - (b)(4).Date collected - (b)(6) 2017 at 15:15.Flagged positive at the 3d - (b)(6) 2017 at 02:22.Isolate displayed growth from media plates on: (b)(6) 2017.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from the united states notified biomérieux of a gram negative possible bacillus contamination associated with bact/alert® sn bottles for three (3) patients were involved.An investigation was performed.Data files were analyzed from the b.50 backup made on (b)(6) 2017.All three bottles flagged positive on the acceleration algorithm; two flagged positive around 36 hours and one around 28 hours.All three positive bottles were unloaded and reloaded by the customer.The customer reported that two patient samples were confirmed by (b)(6) lab as camplylobacter conscious.The third patient sample was confirmed to be camplylobacter showae by their internal testing.A 100% visual inspection was performed on 300 retained bottles from bact/alert® sn lot number 1048286, and zero bottles exhibited evidence of contamination, a yellow sensor, or foreign material in the bottle.Later, the customer reported that they performed an internal investigation and stated it may have been a coincidence to recover uncommon organisms close together.No potential contamination problems have been seen since.A review of the manufacturing and quality records for bact/alert® sn bottle lot 1048286 confirmed there were no non sterile units (nsus) associated with the packaging of lot 1048286, and that the lot met all release criteria.The instructions for use (ifu) was reviewed (bact/alert® sn ifu, 9311983 d 2016-03) and was verified to contain sufficient instructions related to the subject event for both the inspection of the bottle and contamination prevention.Patient details were reviewed: patient 1: (b)(6) patient 2: (b)(6), on the solid organ transplant floor patient 3: (b)(6), in the cancer center upon review, it was determined the results most likely to be true positives, not false positives from contamination, and the bottles performed as intended.Sepsis is more likely in the young and elderly, and others with compromised immune systems.Campylobacter is not considered a skin contaminant or a manufacturing contaminant and would be easily killed during the final autoclave step in production.The bottles flagged positive and upon subculture grew campybacter concisus and campybacter showae.This behavior is expected, and is not a product malfunction.Review of manufacturing and qc records indicate no contamination was present in the bottles at time of product release.

• Brand Name: BACT/ALERT® SN CULTURE BOTTLE
• Type of Device: BACT/ALERT® SN CULTURE BOTTLE
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• MDR Report Key: 7027288
• MDR Text Key: 93097505
• Report Number: 3002769706-2017-00360
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026055813
• UDI-Public: 03573026055813
• Combination Product (y/n): N
• PMA/PMN Number: K021123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

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: 01/13/2018
• Device Catalogue Number: 259790
• Device Lot Number: 1048286
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/14/2017
• Supplement Dates Manufacturer Received: 01/19/2018
• Supplement Dates FDA Received: 01/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 5 MO