MAUDE Adverse Event Report: I-SENS, INC. RELION PREMIER VOICE BLOOD GLUCOSE TEST SYSTEM; SYSTEM, TEST, BLOOD GLUCOSE,OVER THE COUNTER

Model Number	780001 / 780100
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The meter and strips involved in the incident were not returned for investigation.The retain strips of the specified lot were tested with a qs meter and passed testing with no failures detected.If the customer returns any complaint products, the products will be tested and a follow-up mdr will be filed.
Event or Problem Description
The customer reported that two different meters, a relion premier classic and a relion premier voice, and two different lots of premier test strips are reading too low which caused her to believe that her blood sugar was too low, so she drank orange juice to raise her blood glucose levels and ended up going to the emergency room to be treated.She stated her normal blood glucose levels are 90-100, however, sometimes she receives levels in higher hundreds to lower two hundreds.She was receiving results of 50-60 testing with these products.When asked about hand cleansing, using new lancets, and blood testing techniques, she described proper blood testing techniques.When asked about control solution and testing the meter and strips with control solution to check for accuracy, she stated she does not have control solution and doesn't know what control solution is.She initially did not seek medical treatment and continued to test with each meter and test strips and continued to receive low blood glucose readings and continued to drink more orange juice based on the low blood glucose readings and eventually felt something was not right, however, she was not experiencing any symptoms, but then went to the emergency room to seek medical treatment.She stated she did not treat herself with any medications or alter her medications based on the readings she received.The emergency room confirmed that her blood glucose was too high, and she was experiencing hyperglycemia.She was admitted to the hospital overnight and was treated by needing iv fluids, a double dose of insulin to lower her blood sugar level, and monitoring.Replaced meter, strips, sent control solution and return label.

• Brand Name: RELION PREMIER VOICE 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: 22727538
• Report Number: 1832816-2025-00008
• Device Sequence Number: 21095119
• Product Code: NBW
• UDI-Device Identifier: 00681131169851
• UDI-Public: (01)00681131169851
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 08/06/2025
• Report Date (Section F): 08/06/2025

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: Lay User/Patient
• Device Model Number: 780001 / 780100
• Device Catalogue Number: 780001 / 780100
• Device Lot Number: XB16BBZRA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/10/2025
• Event Location: Home
• Date Report to Manufacturer: 08/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2025
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Date Report Sent to FDA: 08/06/2025