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.Issue description: a notification was received from biofire that they had received a customer complaint from the united states of a false positive bcid2 results associated with a strain tested on with the bact/alert pf plus (plastic) 100 btls -ref.(b)(4), lot 0004101958.Summary: bcid: serratia marcescens bact/alert culture bottle: negative the customer confirmed that they only notified biomerieux of the event as a response to a biofire field action "fa-twd-000005 - biofire - biofire bcid2 - bactalert® culture bottles".The bact/alert bottle is a qualitative test, detecting the presence or absence of an organism.There is a possibility of the presence of nucleic acids from non-viable microorganisms in the media used in the bact/alert bottles.The presence of nucleic acids from non-viable microorganisms, alone, will not cause the bact/alert bottle to flag as positive for growth as the organism is not viable and cannot grow in the bottle.The physician should use all information available on the patient to interpret the biofire® filmarray® bcid2 panel results accordingly.The presence of contaminating nucleic acid from non-viable microorganisms in the media, not from the patient sample, is a possibility that must be considered when interpreting the biofire® filmarray® bcid2 panel results.
Additional Manufacturer Narrative
(b)(6) 2024: issue description has been corrected to document the correct lot number and 4 impacted patients.See section b5 for updated detail.
Event or Problem Description
(b)(6) 2024: issue description has been corrected to document the correct lot number and 4 impacted patients.See below for updates.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.Issue description: a notification was received from biofire that they had received a customer complaint from the united states of false positive results associated with bact/alert pf plus (plastic) 100 btls - ref.(b)(4), lot 0004102452.Summary: - patient 1: -- bcid2: s.Marcescens.-- bact: negative.- patient 2: -- bcid2: s.Marcescens.-- bact: negative.- patient 3: -- bcid2: s.Marcescens.-- bact: negative.- patient 4: -- bcid2: s.Marcescens.-- bact: negative.The bact/alert bottle is a qualitative test, detecting the presence or absence of an organism.There is a possibility of the presence of nucleic acids from non-viable microorganisms in the media used in the bact/alert bottles.The presence of nucleic acids from non-viable microorganisms, alone, will not cause the bact/alert bottle to flag as positive for growth as the organism is not viable and cannot grow in the bottle.The physician should use all information available on the patient to interpret the biofire® filmarray® bcid2 panel results accordingly.The presence of contaminating nucleic acid from non-viable microorganisms in the media, not from the patient sample, is a possibility that must be considered when interpreting the biofire® filmarray® bcid2 panel results.

• 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 27712
• Manufacturer (Section G): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• Manufacturer Contact: benjamen jost ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 20605802
• Report Number: 3002769706-2024-00054
• Device Sequence Number: 12596834
• Product Code: MDB
• UDI-Device Identifier: 03573026357924
• UDI-Public: 03573026357924
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K121446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 11/13/2024
• 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 Sex: Unknown