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

Model Number	100603503
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer complained that the control solution out of the range problem.Manufacturing records will be reviewed right after receiving the control solution and test strips serial number and other information.The control solution and test strips is not returned yet.Relevant investigation will be initiated after receiving those information.The user has not yet provided the nonconforming control solution and strips 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.
Event or Problem Description
Customer complainted that the control solution out of the range problem.

• Brand Name: LEMV
• 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: 21330064
• Report Number: 3004130086-2025-00003
• Device Sequence Number: 21006789
• 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): 02/06/2025

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: 100603503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 02/07/2025
• 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