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

Model Number	100702332
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue lies in the incompatibility between the self-monitoring blood glucose system meter software and the computer version.It is recommended to upgrade the transfer software to the latest version glucomanager 4.07 to improve compatibility with win 10 system.However, the meter's detection functionality and data recording are normal.
Event or Problem Description
Customer complaint that the customer's self-monitoring blood glucose system meter would not download data with the software.(model emng).

• Brand Name: EMNG
• 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: 19077187
• Report Number: 3004130086-2024-00005
• Device Sequence Number: 6030611
• Product Code: NBW
• UDI-Device Identifier: 10885017000321
• UDI-Public: (01)10885017000321(17)230430(10)278212901
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2024

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 Expiration Date: 04/30/2023
• Device Model Number: 100702332
• Device Lot Number: 278212901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown