MAUDE Adverse Event Report: EPS BIO TECHNOLOGY CORP. EASYMAX V; SELF-MONITORING BLOOD GLUCOSE SYSTEM

Catalog Number	100603503
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer complained that the control solution was out of range.
Additional Manufacturer Narrative
The customer complained that the control solution was out of range.The control solution, test strips, and meter have not yet been returned.Upon receiving the serial number information for the control solution, test strips, and meter, we will promptly review the production records and initiate the relevant investigation.The user has not yet provided the nonconforming meter or related information.The fields for lot or batch number, serial number, and manufacturing date cannot be filled in.If the user provides the relevant information later, it will be filled in accordingly.

• Brand Name: EASYMAX V
• Common Device Name: SELF-MONITORING BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): EPS BIO TECHNOLOGY CORP.; no.8 r&d rd iii; hsinchu science park; hsinchu county, TW 30 076; TW TW 30076
• Manufacturer (Section G): EPS BIO TECHNOLOGY CORP.; no.8 r&d rd iii; hsinchu science park; hsinchu county, TW 30 076; TW TW 30076
• Manufacturer Contact: evelyn huang ; no.8 r&d rd iii; hsinchu science park; hsinchu county, TW 30-076 ; TW TW 30076
• MDR Report Key: 22147878
• Report Number: 3004130086-2025-00008
• Device Sequence Number: 8308713
• Product Code: NBW
• UDI-Device Identifier: 00885017000058
• UDI-Public: 00885017000058
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K092894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• 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
• Device Catalogue Number: 100603503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Male