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

Model Number	784001
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6).Lot eb4031102 - (b)(6) 2025 - 50ct.The customer reported receiving variable readings.The customer tested last night, and the first test was high, and the second test one hour later was low.He did not take any insulin.Customer reported that on 11/29/2023, his blood sugar read high at 440.He took the amount of insulin that was recommended, 10 units of glargine and 10 units of novolog, his wife was with him and heard him moaning.He rolled out of bed on the floor.His wife called the paramedics.He was passed out when they arrived.The customer passed out for about an hour.The paramedics checked his glucose, and it was 39.They treated him with meds, but he has no idea what they gave.They treated him at home.He woke up and told them he did not want to go to the hospital.Before they left, they took his blood sugar, and it was 140.He said they checked it three or four times as it was gradually getting better.It went from 80 to 140.He said he doesn't know if the problem is with the meter or him.He also mentioned he took a blood test last night and that result was 364.He did not take insulin.Two hours later, without taking insulin or medication, he stood up and he felt dizzy.He took his blood test, and the reading was 65.He has changed his diet.He lost 30 pounds.He stores the meter and strips in an unused bathroom.He is not receiving oxygen therapy.He doesn't have trouble getting a sample of blood.He changes the lancets each time he tests.He uses alcohol to clean his fingertip and allows it to dry thoroughly.Replaced meter, strips and sent return label.
Additional Manufacturer Narrative
Customer did not return meter or strips involved in incident.Meter and strips involved in incident will not be returned for investigation as the customer advised during a follow-up call that he discarded the items.Retain strips of specified lot were tested with qs meter and passed testing with no failures detected.

• Brand Name: RELION PREMIER CLASSIC 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: 18443001
• Report Number: 1832816-2024-00001
• Device Sequence Number: 6826322
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)00681131280624,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/04/2023
• Report Date (Section F): 01/04/2023

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 Expiration Date: 05/02/2025
• Device Model Number: 784001
• Device Catalogue Number: 784001
• Device Lot Number: EB4031102
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/14/2023
• Event Location: Home
• Date Report to Manufacturer: 01/04/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2024
• 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; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Date Report Sent to FDA: 01/04/2023