MAUDE Adverse Event Report: I-SENS, INC. ASSURE PRISM BLOOD GLUCOSE TEST SYSTEM; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number	530001
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer returned meter and 8 strips of specified strip lot.Returned meter was tested with returned test strips and retain strips.Meter and returned strips and retain strips passed testing with no failures detected.Products will be forwarded to manufacturer.
Event or Problem Description
Caller is reporting that they have had two incidents with this meter, the first one on (b)(6) 2024 and the second one on (b)(6) 2024, where the meter was reading lower than blood readings at the hospital.Meter and strips are always stored on the rig in normal conditions.For the first incident on (b)(6) 2024, caller reported that the ems reading with this meter was 396 at 9:26 am on (b)(6) 2024, the hospital capillary reading was somewhere in the 500's, and the lab test result was about 621.For the second incident on (b)(6) 2024, the reporter did not have specific details on the readings that were received, only that they were lower.Replaced meter, strips, sent control solution and sent return label.This report is in reference to the first incident on (b)(6) 2024.

• Brand Name: ASSURE PRISM BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): I-SENS, INC.; 43, banpo-daero 28-gil; seocho-gu; seoul, 06646 ; KS 06646
• MDR Report Key: 19101028
• Report Number: 1832816-2024-00008
• Device Sequence Number: 7427956
• Product Code: NBW
• UDI-Device Identifier: 00015482530013
• UDI-Public: (01)00015482530013
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/08/2024
• Report Date (Section F): 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2025
• Device Model Number: 530001
• Device Catalogue Number: 530001
• Device Lot Number: WY08MAKMA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/18/2024
• Event Location: Home
• Date Report to Manufacturer: 04/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 6 MO
• Patient Sex: Female
• Date Report Sent to FDA: 04/12/2024