MAUDE Adverse Event Report: BIGFOOT BIOMEDICAL, INC BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

Model Number	ASM-10049
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following the submission of a correction/removal for certain bigfoot unity devices, it has been determined that this complaint is a reportable malfunction.
Event or Problem Description
A customer reported receiving device error from a bigfoot unity device.This is a known issue for the serial number associated with this complaint, addressed by the field action fa-001 (fda recall 3016525500/05162025/c).There was no report of death, serious injury, or mistreatment associated with this event.
Event or Problem Description
A customer reported receiving device error from a bigfoot unity device.This is a known issue for the serial number associated with this complaint, addressed by the field action fa-001 (fda recall 3016525500/05162025/c).There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
This serves as a correction report.Section d4 (primary udi number) was incorrectly documented in the previous report.Correction has been made.

• Brand Name: BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM
• Common Device Name: DIABETES MANAGEMENT SYSTEM
• Manufacturer (Section D): BIGFOOT BIOMEDICAL, INC; 1820 mccarthy boulevard; milpitas CA 95035
• Manufacturer (Section G): BIGFOOT BIOMEDICAL, INC; 1820 mccarthy boulevard; milpitas CA 95035
• Manufacturer Contact: deanne krenz ; 1820 mccarthy boulevard; milpitas, CA 95035 ; 6698329510
• MDR Report Key: 22598907
• Report Number: 3016525500-2025-00044
• Device Sequence Number: 4083762
• Product Code: QLG
• UDI-Device Identifier: 00850003506166
• UDI-Public: (01)00850003506166(21)TL242340007
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K202145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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: Lay User/Patient
• Device Model Number: ASM-10049
• Device Catalogue Number: ASM-10049
• Device Lot Number: 45871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3016525500/05162025/C
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Unknown