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

Catalog Number 251062

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in the united states notified biomerieux of a false negative result associated with bact/alert® ifa (reference 251062).The customer reported that the result is likely a false negative due to the color of the indicator and they tested the sample in a ifn bottle which flagged positive after three (3) days.The customer switched the bottle early on in incubation to another incubator.The customer is gram staining and sub culturing to verify if the result is a true positive.This is an industry customer and there is no patient associated with the event.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

Correction: 1950204-2018-00219 was initially reported as against the bact/alert® i fa (ref 251062) in initial report 3002769706-2018-00004 in error.A supplemental report was then submitted as against the bact/alert® 3d instrument (reference 210148) 1950204-2018-00219.1950204-2018-00219 has been resubmitted as an initial report in response to an fda request regarding missing initial medwatch reports.A supplemental report for 3002769706-2018-00004 is also being submitted as a correction.

• Brand Name: BACT/ALERT IFA
• Type of Device: BACT/ALERT® IFA
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• MDR Report Key: 7168421
• MDR Text Key: 96721587
• Report Number: 3002769706-2018-00004
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• PMA/PMN Number: K020813
• 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: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 251062
• Device Lot Number: 1048942
• Other Device ID Number: 03573026162719
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1