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); Vomiting (2144)
Date of Event	02/12/2023
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
Patient tested hi on their own personal meter.Patient was vomiting due to high blood glucose.Paramedics were called.Patient was picked up by paramedics on (b)(6) 2023 at 8:37 am.When the paramedics arrived, they tested the patient with the assure prism meter and received a reading of 350.They did not treat the patient based on this reading because they were unsure if the meter was reading correctly.Paramedics transferred patient to hospital.Patient was tested there, with their meter, and they received a reading of 570.The treatment that hospital provided is unknown.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: 16552942
• Report Number: 1832816-2023-00004
• Device Sequence Number: 5088582
• Product Code: NBW
• UDI-Device Identifier: 00015482530501
• UDI-Public: (01)00015482530013,(01)00015482530501
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2023
• Report Date (Section F): 03/16/2023

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: Health Professional
• Device Expiration Date: 07/09/2024
• Device Model Number: 530001
• Device Catalogue Number: 530001
• Device Lot Number: UU10MACHC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/21/2023
• Event Location: Home
• Date Report to Manufacturer: 03/16/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2023
• 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: 47 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Date Report Sent to FDA: 03/16/2023