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	Chest Pain (1776); Hyperglycemia (1905)
Date of Event	06/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, (b)(6) fire department received a call for chest pains.Upon arrival, patient was conscious, and she was exhibiting signs of low blood glucose.The fire department did a blood glucose test with the assure prism meter and received a reading of 31.Fire department personnel had her eat a peanut butter and jelly sandwich and drink some sweet tea.They checked her blood glucose again 10 minutes later with the assure prism meter and the reading was 32, which seemed unusual.The ems crew arrived to take over the situation, and when they tested the patient's blood glucose with their meter, the reading was 480.The fire department left, and ems personnel transported patient to the hospital where it is unknown what kind of treatment she received.When caller returned to the fire department after the call, the caller performed a blood glucose test on himself with the assure prism and received a reading of 41.Caller performed a control solution test with the assure prism using l2 control solution and received a reading of 31 and the range for the l2 control solution was 31, indicating the meter was still reading low, even with control solution.The same control solution was used to test other assure prism meters that the caller had, and those test results were within range.Replaced meter, strips and sent return label.
Additional Manufacturer Narrative
Meter involved in incident was returned for investigation.Customer did not return strips, so retain strips of specified lot were used for testing.Meter and retain strips were tested with both blood and reference control solution lot csub28cm, expiration 2024-05-27.Products performed to specification.No failure detected.Products will be forwarded to manufacturer.

• 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: 17316303
• Report Number: 1832816-2023-00015
• Device Sequence Number: 6226269
• Product Code: NBW
• UDI-Device Identifier: 00015482530501
• UDI-Public: (01)00015482530013,(01)00015482530501
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/21/2023
• Report Date (Section F): 07/13/2023

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: 08/05/2024
• Device Model Number: 530001
• Device Catalogue Number: 530001
• Device Lot Number: UL06MAD3A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/21/2023
• Event Location: Home
• Date Report to Manufacturer: 07/13/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2023
• 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: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Date Report Sent to FDA: 07/13/2023