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 Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	02/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Meter and strips involved in incident were returned for investigation, evaluated, and tested.Products performed to specification.No failure detected.Products will be forwarded to manufacturer.
Event or Problem Description
Customer had sent an email stating that the glucose monitors are reading several points off from the hospital readings.When this begins to happen (after about six months of use) we end up replacing them.As recently as last week, we had a reading of 300, our local fire department had a reading of 500, and the hospital obtained a reading of 1100.This was a critical patient in diabetic ketoacidosis who required intubation.Arkray followed up with customer by phone.Verified the readings were within 20 minutes of each other.Customer stores meter and test strips together in the ambulance in a medical bag in the back of the ambulance.Meters are stored in a temperature-controlled environment of 68-72 degrees.Customer said that the incident occurred on (b)(6) 2024 at about 10:33 pm.They received a call that a patient was unresponsive.Ems arrived at the patient's home, took her glucose reading and gave her oxygen.Patient takes novolog and victoza for type 2 diabetes.She doesn't use oxygen normally but was given oxygen upon arrival at her home.Verified that customer seals the test strip bottle immediately after removing a strip.Verified they used alcohol to clean the patient's fingers, used a new sterile lancet, and they wiped away the first drop then used the second drop of blood to test.They used a fresh sample of capillary blood from the fingertip.The patient was transported to the hospital.The patient was hypotensive and was given epinephrine.The patient is still alive.Replaced meter, strips and sent return label.

• 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: 18931638
• Report Number: 1832816-2024-00007
• Device Sequence Number: 21173339
• Product Code: NBW
• UDI-Device Identifier: 00015482530013
• UDI-Public: (01)00015482530013
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/11/2024
• Report Date (Section F): 03/19/2024

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: 08/24/2025
• Device Model Number: 530001
• Device Catalogue Number: 530001
• Device Lot Number: WL27MAM7B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/26/2024
• Event Location: Home
• Date Report to Manufacturer: 03/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2024
• 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; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female
• Date Report Sent to FDA: 03/19/2024