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

Catalog Number 410851

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Event Description

A customer from the united states reported to biomérieux a contamination issue in association with the bact/alert® fa plus bottle (lot 3048555).The customer reported that two bottles grew gram positive rods and two more bottles are showing the same gram morphology.There is no indication or report from the customer to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

Item "hospitalization - initial or prologed" should not be selected.

Manufacturer Narrative

A customer from the united states reported to biomérieux a contamination issue in association with the bact/alert® fa plus bottle (lot 3048555).The customer reported that two bottles grew gram positive rods and two more bottles are showing the same gram morphology.An investigation was performed.During the course of the investigation, there were no issues identified to suspect contamination that was introduced in the bottles during the production process of bact/alert® fa plus bottle lot 3048555.There is no evidence of an event occurring during the manufacturing process that would have led to the contamination observed at the customer site.This is the only report of inoculated bottle contamination with bacillus pumilus during the period reviewed for this investigation.There is no evidence of a systemic issue with bact/alert® 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 on the collection devices as possible sources of contamination.The customer did not indicate any impact to patients due to this 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
• 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: 6691302
• MDR Text Key: 79281652
• Report Number: 3002769706-2017-00157
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121461
• 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,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2018
• Device Catalogue Number: 410851
• Device Lot Number: 3048555
• Other Device ID Number: 03573026357900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization