MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT® FN PLUS

Model Number 410852

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a false negative result for capnocytophaga canimorsus atcc® 35979 external quality control samples in association with the bact/alert® fn plus bottle.The customer stated they received two qc lyophilized samples which they prepared according to guidelines.Two bact/alert® fn plus bottles were inoculated with 5 mls of blood culture suspension at > 10^3 concentration.The first sample was flagged positive and identified as bacteroides fragilis.The second sample was not flagged positive after five days.The bottle was incubated three more days and remained negative for a total of eight days.Testing of another suspension of that second sample with a higher concentration resulted in no growth.A subculture of the negative bottles was performed and there was no growth.There was no patient involvement as this was a quality control 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® fa plus bottles p/n 410851, lot number 3047552 and bact/alert® fn plus bottles p/n 410852 lot 3047513 manufacturing directions, including the quality control release testing documentation, and all results were within specification quality assurance subsequently released the lots for distribution to the field.Historical review of complaint data, capa and nonconformance trends determined this was an isolated incident relating to this proficiency test.There is no evidence there is a systemic issue with bact/alert® fa plus or fn plus bottles.In an article in emerging infectious diseases, capnocytophaga canimorsus is described as a fastidious organism often difficult to isolate and identify and may require extended incubation periods.Janda jm, graves mh, lindquist d, probert ws.Diagnosing capnocytophaga canimorsus infections.Emerg infect dis.2006 feb 12.Per the bact/alert® fa plus and bact/alert® fn plus instructions for use, certain rare, fastidious microorganisms will not grow or may grow slowly in the bact/alert® fa plus culture bottle growth medium.In addition, on rare occasions, organisms may be encountered that grow in the bact/alert® fa plus and bact/alert® fn plus culture bottle growth medium but do not produce sufficient carbon dioxide to be determined positive.Given that the test provider, lab quality, did not score the sample, poor sample viability is the most likely root cause for false negative results for the capnocytophaga canimorsus proficiency sample in bact/alert fa plus bottle.

Manufacturer Narrative

302769706-2017-00178 supplement 1 was sent without data in (date of this report).The date, 11sep2017, should have been included on this supplement medwatch report.

• Brand Name: BACT/ALERT® FN PLUS
• Type of Device: BACT/ALERT® FN 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; saint louis, MO 63042
• MDR Report Key: 6706691
• MDR Text Key: 79951407
• Report Number: 3002769706-2017-00178
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026357917
• UDI-Public: 03573026357917
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: K121455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2017
• Device Model Number: 410852
• Device Lot Number: 3047513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1