MAUDE Adverse Event Report: BIOMERIEUX, INC BACT/ALERT® 3D INSTRUMENT

Model Number 248009

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from the (b)(6) reported to biomérieux a false negative culture bottle with slow growing contamination in association with the bact/alert® 3d 60 instrument.The customer reported the bottle was flagged as a false negative although the graph showed a change in reflectance during the first day, and the sample was clearly positive with a change in bottle base color with lumps in the media.The customer reseeded another bottle from this one and it was positive.The customer sent a sample of the culture to an external lab which identified the contaminant as paracoccus yeei.The customer stated there was no impact on the product or patient.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.The customer stated the bact/alert® 3d 60 instrument was overdue for service.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: the instrument is performing as expected.There were no bottle movements, instrument faults, or operator errors and the bottle was tested under the correct algorithm.The algorithm uses 3 methods (initial value threshold, acceleration and rate) to determine if a bottle is positive.This bottle did not meet any of these requirements to be flagged as positive.The biomath group confirmed with an algorithm tool, that the bottle should have been reported as negative; no lag phase was observed, accompanied with a minimal log phase.The false negative result is potentially due to either a high inoculum level of sample, delayed entry into the instrument, or organism growth had occurred prior to the sample being inoculated in the bottle.

Manufacturer Narrative

(b)(4).

• Brand Name: BACT/ALERT® 3D INSTRUMENT
• Type of Device: BACT/ALERT® 3D INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• MDR Report Key: 6691315
• MDR Text Key: 79652087
• Report Number: 3002769706-2017-00156
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• PMA/PMN Number: K903505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2018

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 Model Number: 248009
• Other Device ID Number: 03573026130725
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1