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 Code	Hypoglycemia (1912)
Date of Event	12/22/2022
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
They have been having issues with these glucometers.They have had three occurrences in the past few weeks where the readings have been off.Reporter was on one call where the patient's free style libre read 55 and the prism read 98.They re-checked after they started an iv and the prism read 102.After arrival to the hospital, they checked again, and it was now 33 on another meter.They swapped to a different monitor on that ambulance, and they had a subsequent call where the patient's own was reading 800, and the prism read 400.Over the weekend, they had a call where the patient read 155, but they were not acting like their glucose was 155, so they were treated, and tested again and the reading was 90.All readings were performed within five minutes of each other.The caller stated the meters are always reading too high.Verified they change the lancets each time they test.They use alcohol to clean fingers and allow finger to dry completely.Patient was not receiving any oxygen therapy.Patient doesn't have trouble getting a blood sample.The meter and test strips are stored together in the back of the ambulance in a temperature-controlled environment.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: 16356248
• Report Number: 1832816-2023-00002
• Device Sequence Number: 6261286
• Product Code: NBW
• UDI-Device Identifier: 00015482532505
• UDI-Public: (01)00015482530013,(01)00015482532505
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 01/17/2023
• Report Date (Section F): 02/10/2023

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: 04/04/2024
• Device Model Number: 530001
• Device Catalogue Number: 530001
• Device Lot Number: UM05MAA2A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/17/2023
• Event Location: Home
• Date Report to Manufacturer: 02/10/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2023
• 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 Age: 65 YR
• Patient Sex: Female
• Date Report Sent to FDA: 02/10/2023