MAUDE Adverse Event Report: BIOFIRE DIAGNOSTICS, LLC BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

Model Number RFIT-ASY-0147

Device Problem False Negative Result (1225)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation: on (b)(6) 2024, a positive blood culture sample was tested on the biofire bcid2 panel.The biofire bcid2 panel reported all analytes as not detected.It is unknown if the patient was impacted due to the biofire bcid2 panel result or if additional testing was performed.Biofire's investigation into this event is ongoing and further information has been requested from the customer.The full investigation and associated conclusions will be provided in the supplemental report.No remedial action, corrective action, preventive action, or fsca has been deemed necessary at this time.Conclusion: investigation ongoing.

Event Description

Summary: a potential false negative staphylococcus epidermidis and meca/c result on the biofire blood culture identification 2 (bcid2) panel occurred on (b)(6) 2024, after testing a patient blood culture sample.Information regarding additional testing and patient impact is unknown.Biofire has requested further information from the customer and is currently investigating this event.No remedial action, corrective action, preventive action, or field safety corrective action (fsca) has been deemed necessary at this time.

Manufacturer Narrative

Investigation: on (b)(6) 2024, a positive blood culture sample was tested on the biofire bcid2 panel.The biofire bcid2 panel reported all analytes as not detected.It is unknown if the patient was impacted due to the biofire bcid2 panel result or if additional testing was performed.Biofire's investigation into this event is ongoing and further information has been requested from the customer.The full investigation and associated conclusions will be provided in the supplemental report.No remedial action, corrective action, preventive action, or fsca has been deemed necessary at this time.Update for follow-up report: biofire has requested more information from the customer in order to determine the root cause.The full investigation and associated conclusions will be provided in the final report.Conclusion: investigation ongoing.

Event Description

Summary: a potential false negative staphylococcus epidermidis and meca/c result on the biofire blood culture identification 2 (bcid2) panel occurred on (b)(6) 2024, after testing a patient blood culture sample.Information regarding additional testing and patient impact is unknown.Update for follow-up report: biofire has requested more information from the customer in order to determine the root cause.The full investigation and associated conclusions will be provided in the final report.

• Brand Name: BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL
• Type of Device: BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL
• Manufacturer (Section D): BIOFIRE DIAGNOSTICS, LLC; 515 colorow dr; salt lake city UT 84108
• Manufacturer (Section G): BIOFIRE DIAGNOSTICS, LLC; 515 colorow dr; salt lake city UT 84108
• Manufacturer Contact: 515 colorow dr; salt lake city, UT 84108 ; 8017366354
• MDR Report Key: 19188466
• MDR Text Key: 341462169
• Report Number: 3002773840-2024-00313
• Device Sequence Number: 1
• Product Code: PAM
• UDI-Device Identifier: 00815381020338
• UDI-Public: 00815381020338
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

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
• Device Operator: Health Professional
• Device Model Number: RFIT-ASY-0147
• Device Catalogue Number: RFIT-ASY-0147
• Device Lot Number: 2637323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1