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	Imprecise or Erratic Results (4059)
Health Effect - Clinical Codes	Hypoglycemia (1912); Confusion/ Disorientation (2553)
Date of Event	01/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer has been having issues with these glucometers.They stated they have had three occurrences in the past few weeks where the readings have been off.They received a call for patient experiencing diabetic problems.He had fallen.He was alert but confused.The patient's son had given honey before the ambulance arrived.They checked the patient's sugar.They received a reading of 155.The paramedics gave him glucose gel, food (sandwich) and juice.They checked him again and the meter read 90, which they feel was incorrect and should have been higher after the honey, the glucose gel, so they think the meter read too high when he was originally tested, and he was low.The patient became alert, and he was able to answer all their questions.He came back to normal.He was not transported to the hospital.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.
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 forward 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: 16355728
• Report Number: 1832816-2023-00001
• Device Sequence Number: 20542210
• 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; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Date Report Sent to FDA: 02/10/2023