MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT PF PLUS (PLASTIC) 100 BTLS - 410853

Catalog Number	410853
Medical Device Problem Code	Cross Reactivity (1137)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Intended use.Bact/alert® pf plus culture bottles are used with bact/alert® microbial detection systems in qualitative procedures for recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.Description of the issue.A customer in united states notified biomérieux of biofire interference for serratia marcescens that was detected using the biofire bcid2 panel for one (1) patient in association with bact/alert pf plus (plastic) 100 btls - 410853 (lot#: 0004102452).Customer reports they had a patient that had a detected s.Marcescens that was reported.There was no gram negatif result in the gram stain, and no s.Marcescens isolated in culture.They said it was a failure in their process due to reporting result without matching gram stain.Patient was a little under 1 month old at time of testing and is female.Results reported to physician: the initial bcid result of serratia marcescens [and s.Aureus (no methicillin resistance)] was reported out to the physician as was their report once they were unable to isolate the serratia.Bcid2 information: sn: (b)(6)1, lot#: 3d3c24/1235724, instrument sn: (b)(6), organisms detected: staphylococcus spp., staphylococcus aureus, enterobacterales, serratia marcescens, ran on (b)(6) 2025 5:56 pm, controls passed, sample is no longer available, sample: a one bottle draw (pediatric bottle) collected from the left hand on (b)(6) 2025.All testing performed: a bcid was run, the bottle was subcultured, and mic testing was done.Growth on subcultures did show s.Aureus and mic testing did confirm that it was mssa.There was no growth of serratia.The pediatric bottle was incubated on bact/alert virtuo, subcultured once flagged positive, and tested on the torch for the bcid.All testing was done from the one pediatric bottle.Gram stain: gram positive cocci in clusters.Culture: staphylococcus aureus (mssa) was grown/reported as the final culture result.Biomérieux global customer service ask the following questions: was there any patient treatment or harm due to incorrect results reported for any of the patients? was any treatment or antibiotic given in response to the serratia result? to date, no additional information was provided by the customer.There is no indication or report from the customer that this event led to or contributed to any death, serious injury, or serious deterioration in the state of health for the concerned patient.

• Brand Name: BACT/ALERT PF PLUS (PLASTIC) 100 BTLS - 410853
• Common Device Name: BACT/ALERT PF PLUS (PLASTIC) 100 BTLS - 410853
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC
• Manufacturer (Section G): BIOMERIEUX INC; 100 rodolphe street; durham
• Manufacturer Contact: céline lacroix-gimon ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 22149798
• Report Number: 3002769706-2025-00034
• Device Sequence Number: 15552101
• Product Code: MDB
• UDI-Device Identifier: 03573026357924
• UDI-Public: 03573026357924
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2025

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: 03/03/2025
• Device Catalogue Number: 410853
• Device Lot Number: 0004102452
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Sex: Female