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

Catalog Number	410852
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in poland notified biomérieux of obtaining two false negative results in association with the bact/alert ® fn plus blood culture bottles (reference 410852, lot 4053043).The customer stated both bottles were incubated for five days and flagged negative.These bottles were then sub-cultured and were positive for growth of propionibacterium acnes (p.Acnes).Although the customer did follow the five day incubation protocol, p.Acnes is a fastidious slow growing microorganism which may require a longer incubation period.The bottle instructions for use (ifu) notes this a limitation of the test if fastidious microorganisms are suspected.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer in poland notified biomérieux of obtaining two false negative results from a single patient in association with the bact/alert ® fn plus blood culture bottle (reference (b)(4), lot 4053043).The customer stated both bottles were incubated for five days and flagged negative.These bottles were then sub-cultured and were positive for growth of propionibacterium acnes (p.Acnes).In response to the customer, complaint biomérieux conducted an internal investigation.The investigation examined the bact/alert® fn plus manufacturing directions, including the quality control release testing documentation; all results were determined to be within specification.Bact/alert® fn plus lot 4053043 met all quality finished goods release criteria and was released by quality assurance on 13-mar-2019.The bact/alert® fn plus instructions for use were reviewed and found to provide sufficient caution for the user on the interpretation of a negative result.The root cause was not determined.The bottle performed as expected based on a review of the data provided from the customer.Potential contributing factors of the false negative result of this fn plus bottle include: 1.The organism, p.Acnes, being a fastidious, slow growing microorganism, may require a longer incubation period than a 5-day protocol.2.In the clinical blood culture sample, p.Acnes can be a contaminant from the skin during the blood collection.In such cases, the contamination may be low-level cfu/bottle, resulting in a time to detection longer than the 5-day test period.The bact/alert ® fn plus blood culture bottle (reference (b)(4), lot 4053043) is functioning as intended.

• Brand Name: BACT/ALERT® FN PLUS
• Common Device Name: BACT/ALERT® FN PLUS
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• MDR Report Key: 8904285
• Report Number: 3002769706-2019-00035
• Device Sequence Number: 19339922
• Product Code: MDB
• UDI-Device Identifier: 03573026357917
• UDI-Public: 03573026357917
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K121455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2020
• Device Catalogue Number: 410852
• Device Lot Number: 4053043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 08/17/2019
• Supplement Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1