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

Catalog Number	410852
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomérieux of false positive results associated with bact/alert® fn plus (reference 410852).The customer reported that eleven bottles were impacted by a potential contamination issue of bacillus cereus species (5 fa plus bottles, 4 fn plus bottles and 2 pf plus bottles).There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was initiated in response to a customer complaint for bacillus cereus contamination in inoculated blood culture bottles, bact/alert® pf plus (p/n 410853), bact/alert® fa plus (p/n 410851), and bact/alert® fn plus ( p/n 410852).The customer was unable to return bottles for the investigation as they had been discarded.The lot numbers and graphs were no longer available as the event occurred in august of 2018.Historical review of complaints found no bacillus cereus contamination trend.Bacillus cereus is a gram-positive, motile, spore-forming, rod-shaped bacterium that is widely distributed environmentally.The most probable root cause was determined to be contamination at the customer site during inoculation.The instructions for use provide adequate information for the prevention of contamination.Clean the bottle septum with one disinfectant wipe per bottle top.Spores are not easily killed by any disinfectant, so the mechanical wiping action picks them up and removes them from the bottle top.If you use the wipe on a second bottle, you may be depositing the spores there.

• 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: 8165993
• Report Number: 3002769706-2018-00251
• Device Sequence Number: 14151237
• Product Code: MDB
• UDI-Device Identifier: 03573026357917
• UDI-Public: 03573026357917
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/11/2019

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: No Information
• Device Catalogue Number: 410852
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1