MAUDE Adverse Event Report: BIOMERIEUX, INC BACT/ALERT® SN

Catalog Number 259790

Device Problems Contamination (1120); Incorrect Or Inadequate Test Results (2456)

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

Event Date 06/27/2017

Event Type  malfunction  

Event Description

A customer from the united states reported to biomérieux bottle contamination in association with the bact/alert® sn bottles for two patient blood cultures.The customer reported the blood cultures were flagged at the instrument, and could not recover the organism from the media, and only observed growth in the broth.Patient 1: patient samples were collected on (b)(6) 2017, and two sn bottles (lots 1078054 & 1047681) were flagged positive on (b)(6) 2017.The patient was a (b)(6) male with a gram positive cocci stain.The customer identified the organism as parvinonas micra.The customer stated that the patient diagnosis and treatment was unknown.Patient 2: patient samples were collected on (b)(6) 2017, and a sn bottle was flagged positive on (b)(6) 2017.The customer stated that the patient diagnosis and treatment was unknown.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: during the course of the investigation, there were no issues identified to suspect contamination was introduced in the bottles during the production process of bact/alert® sn bottle lots 1047681 and 1048054.This is the only report of inoculated bottle contamination with parvimonas micra during the period reviewed for this investigation.There is no evidence of a systemic issue with bact/alert® sn bottles, nor is it believed to be an issue with the manufacturing process itself.As a result, there are no new proposed corrective and/or preventive actions from this investigation.There were no other products, process, or systems impacted as a result of this investigation.No follow-up information had been provided by the customer on their investigation regarding the sample techniques for blood collection as sources of contamination.The customer did not indicate any impact to patients due to this issue.

• Brand Name: BACT/ALERT® SN
• Type of Device: BACT/ALERT® SN
• Manufacturer (Section D): BIOMERIEUX, INC; 100 rodolphe street; durham NC 27712
• Manufacturer (Section G): BIOMERIEUX, INC; 100 rodolphe street; durham NC 27712
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6774982
• MDR Text Key: 83118932
• Report Number: 3002769706-2017-00234
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2017
• Device Catalogue Number: 259790
• Device Lot Number: 1047681
• Other Device ID Number: 03573026055813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1