MAUDE Adverse Event Report: BIOFIRE DIAGNOSTICS, LLC FILMARRAY® TORCH MODULE

Model Number	HTFA-SUB-0103
Medical Device Problem Codes	False Negative Result (1225); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: (b)(6) hospitals private limited ( (b)(6) ) reported a potential false negative escherichia coli result on the biofire blood culture identification 2 (bcid2) panel after testing a patient's sample.It is unknown if the patient was impacted due to the biofire bcid2 result.A malfunction of the filmarray torch instrument ( (b)(6) ) is suspected.A final report with all investigation details will be provided.No remedial action, corrective action, preventive action, or field safety corrective action (fsca) has been deemed necessary at this time.Conclusion: investigation ongoing.
Event or Problem Description
Summary:(b)(6) hospitals private limited ( (b)(6) ) reported a potential false negative escherichia coli result on the biofire blood culture identification 2 (bcid2) panel after testing a patient's sample.It is unknown if the patient was impacted due to the biofire bcid2 result.A malfunction of the filmarray torch instrument ( (b)(6) ) is suspected.A final report with all investigation details will be provided.No remedial action, corrective action, preventive action, or field safety corrective action (fsca) has been deemed necessary at this time.
Additional Manufacturer Narrative
Summary: (b)(6) ((b)(6), india) reported a potential false negative escherichia coli result on the biofire blood culture identification 2 (bcid2) panel after testing a patient's sample.It is unknown if the patient was impacted due to the biofire bcid2 result.A malfunction of the filmarray torch instrument (b)(6) was suspected and investigated.After investigation, it was found that this does not meet criteria for a reportable event.There was no occurrence of a malfunction that would cause or contribute serious injury or death if it were to recur.No remedial action, corrective action, preventive action, or field safety corrective action (fsca) has been deemed necessary at this time.Investigation: (b)(6) ((b)(6), india) reported a potential false negative escherichia coli result on the biofire blood culture identification 2 (bcid2) panel after testing a patient's sample.It is unknown if the patient was impacted due to the biofire bcid2 result.A malfunction of the filmarray torch instrument (b)(6) was suspected and investigated.Update final report: after investigation, it was found that this does not meet criteria for a reportable event.There was no occurrence of a malfunction that would cause or contribute serious injury or death if it were to recur.No remedial action, corrective action, preventive action, or field safety corrective action (fsca) has been deemed necessary at this time.Conclusion: update final report: after investigation, it was found that this does not meet criteria for a reportable event.There was no occurrence of a malfunction that would cause or contribute serious injury or death if it were to recur.
Event or Problem Description
Summary: (b)(6) ((b)(6) india) reported a potential false negative escherichia coli result on the biofire blood culture identification 2 (bcid2) panel after testing a patient's sample.It is unknown if the patient was impacted due to the biofire bcid2 result.A malfunction of the filmarray torch instrument (b)(6) was suspected and investigated.After investigation, it was found that this does not meet criteria for a reportable event.There was no occurrence of a malfunction that would cause or contribute serious injury or death if it were to recur.No remedial action, corrective action, preventive action, or field safety corrective action (fsca) has been deemed necessary at this time.

• Brand Name: FILMARRAY® TORCH MODULE
• Common Device Name: FILMARRAY® TORCH MODULE
• 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: 20424577
• Report Number: 3002773840-2024-00407
• Device Sequence Number: 15418990
• Product Code: NSU
• UDI-Device Identifier: 00815381020277
• UDI-Public: 00815381020277
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K160068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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 Model Number: HTFA-SUB-0103
• Device Catalogue Number: HTFA-SUB-0103
• Device Lot Number: N/A
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown