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	High Readings (2459)
Health Effect - Clinical Codes	Hypoglycemia (1912); Altered State of Consciousness (4589)
Date of Event	07/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Meter and strips involved in incident were not returned for investigation.Retain strips of specified lot were tested with qs meter and passed testing with no failures detected.If customer returns any complaint products, products will be tested and a follow-up mdr will be filed.
Event or Problem Description
Caller stated they received the meter two months ago.Caller stated the meter and strips are stored on the ambulance.Caller stated they were called for an unresponsive patient.They tested the meter twice with the patient and received blood glucose readings of 219 ( (b)(6) 2024 at 8:09 pm) and 212 ( (b)(6) 2024 at 8:08 pm).The patient was not treated by the ambulance personnel based on the readings they received.The ambulance crew activated stroke protocol.They transported the patient to the emergency room and the emergency room tested the patient's blood glucose with their meter and registered their blood glucose at 54.The caller stated this meter is reading too high based on the readings received with this meter and the reading that was received at the emergency room.The emergency room further treated the patient with activated stroke protocol and medications, but their complete course of treatment is unknown.Replaced meter, strips, sent control solution and sent return label.
Additional Manufacturer Narrative
The meter and 36 strips that were involved in the incident were returned for investigation.The returned complaint products were forwarded to the manufacturer (i-sens) for further investigation.The returned meter and returned test strips both passed testing with no failures detected.

• 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: 19968215
• Report Number: 1832816-2024-00013
• Device Sequence Number: 8897479
• Product Code: NBW
• UDI-Device Identifier: 00015482530013
• UDI-Public: (01)00015482530013
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024
• Report Date (Section F): 09/13/2024

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: 11/22/2025
• Device Model Number: 530001
• Device Catalogue Number: 530001
• Device Lot Number: WN01MAPLB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/25/2024
• Event Location: Home
• Date Report to Manufacturer: 09/13/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/13/2024
• 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: 85 YR
• Patient Sex: Male
• Patient Weight: 156 KG
• Date Report Sent to FDA: 09/13/2024