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

Model Number	100702332
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Set up does not go past the year 2021 of the self-monitoring blood glucose meter (model emng).
Additional Manufacturer Narrative
Customer complaint that the self-monitoring blood glucose meter when setting the date and time, it just goes to 2021 and then starts over again.(model emng).Conclusion is the firmware has been updated since 2019.The meter has expired (expiry until 2021), and this issue has been addressed by releasing new firmware in 2019.

• Brand Name: EASYMAX NG
• 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: 20503093
• Report Number: 3004130086-2024-00014
• Device Sequence Number: 8222445
• Product Code: NBW
• UDI-Device Identifier: 01885017000323
• UDI-Public: 01885017000323
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K121207
• 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): 10/22/2024

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: Lay User/Patient
• Device Model Number: 100702332
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Male