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 Code	Hyperglycemia (1905)
Date of Event	10/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Meter and strips involved in incident were returned for investigation, evaluated, and tested.Retain strips were also evaluated and tested.All products performed to specification.No failure detected.Products will be forwarded to manufacturer.
Event or Problem Description
The caller reported that a meter was reading low.The caller stated that he was not there when the incident happened, but his team was there.The caller stated that when his team used the assure prism on the patient, they received a reading of 221 at 1:44 am on (b)(6) 2023.The caller stated that when they took the patient to the hospital, the lab work on the patient stated their blood glucose was 600.The caller stated that it was 10 to 15 minutes between when they took the patient's blood sugar with the meter and doing lab work on the patient.The caller stated that he does not know what the reading was for the control solution, but the control solution reading was in range.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: 18170637
• Report Number: 1832816-2023-00017
• Device Sequence Number: 7746121
• Product Code: NBW
• UDI-Device Identifier: 00015482530501
• UDI-Public: (01)00015482530013,(01)00015482530501
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 11/20/2023
• Report Date (Section F): 11/20/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2025
• Device Model Number: 530001
• Device Catalogue Number: 530001
• Device Lot Number: WF22MAJUA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/30/2023
• Event Location: Home
• Date Report to Manufacturer: 11/20/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2023
• 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; Hospitalization; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/20/2023