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

Catalog Number 259797

Device Problem False Negative Result (1225)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in the (b)(6) notified biomérieux of discrepant results associated with the bact/alert® mp culture bottle (reference 259797).The customer reported a false negative result.The customer reported that when they received the eqa material they processed it per their protocol and inoculated the solid medium (sloped agar li medium) and inoculated the bottle on (b)(6) 2017.The material on the solid medium provided obvious growth after twenty (20) days, and the mp bottle was still negative.The bottle was unloaded on (b)(6) 2017 and subcultured the following day.The customer indicated that the results of the subculture will be available in a few weeks.The sample tested belonged to an external quality assessment (eqa) and not a patient sample.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: the investigation examined the bact/alert® manufacturing directions, including the quality control release testing documentation and environmental monitoring data, and all results were within specification.Growth performance was performed for m.Tuberculosis and m.Intracellular; all bottles met the time to detection specification.Quality assurance subsequently released the lot for distribution to the field.Historical review determined this complaint to be an isolated incident.The complaint was received from one (1) customer site for a recovery issue regarding bact/alert® mp bottle results.The root cause of the complaint could not be determined but is most likely due to under inoculation of the bottle, no organisms present in the inoculum, the number of organisms present in the inoculum were too small for detection, or poor viability.No irregularities or similar issues have been reported for the bact/alert® mp product.Based on all available information including the details provided by the customer, reflectance curves, and the instructions for use (ifu), the bottles functioned correctly.

• Brand Name: BACT/ALERT® MP CULTURE BOTTLE
• Type of Device: BACT/ALERT® MP CULTURE BOTTLE
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• MDR Report Key: 7074169
• MDR Text Key: 94639106
• Report Number: 3002769706-2017-00386
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• PMA/PMN Number: K031737
• 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: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2018
• Device Catalogue Number: 259797
• Device Lot Number: 1048508
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1