MAUDE Adverse Event Report: I-SENS, INC. ASSURE PRISM MULTI 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	Hyperglycemia (1905)
Date of Event	09/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On patient, customer received reading of 244 which seemed high to customer, so they had "rescue" (after further listening this is presumed to be the fire department) check the patient with their monitor, and it read 180."rescue" ended up taking the patient to the hospital.At the hospital the reading was 178.This all occurred with 20 minutes, so caller stated the patient couldn't have burned that much sugar.Caller is concerned that they will undertreat or overtreat if the readings on the meters aren't correct.Caller stated they just started using the assure prism meter system.Rep then checked variance of numbers.Variance is 26-27% and readings are all in zone a.Rep then offered to troubleshoot with the caller.Caller stated he tested controls with the meter, and they were in range.Caller stated the ranges are way too broad and don't reflect that a meter is as accurate as it should be.Rep then gathered caller's facility name, address, and phone number.The original call was regarding a patient who had overheated, was weak and dizzy and was a borderline diabetic.The medics checked and received the reading of 244.The patient hadn't eaten or taken any medication.The time between the readings of 244 and 180 was less than seven to eight minutes max according to the caller.Both tests were done via capillary testing, and caller is unsure if same finger was used for testing or not.Patient had been working on a roof in the heat and had become hot.The medics determined that patient was having hyperglycemia.Meters are kept in a jump bag in the ambulance in an air-conditioned climate-controlled environment.Patient's finger was cleansed with alcohol swab and allowed to dry before lancing finger.Test strips are stored in the original bottle and are not mixed.Caller then had questions about when to test with control solution and rep explained instances where control solution testing is encouraged.Rep then gathered meter serial number and strip lot information and explained replacement of meter, strips and return process.
Additional Manufacturer Narrative
Meter involved in incident was returned for investigation.Meter was evaluated and tested with retain strips of specified lot involved in incident.Products performed to specification.No failure detected.This mdr was submitted late due to technical issues with webtrader esg.Fda helpdesk provided assistance through fda esg helpdesk ticket number (b)(4).

• Brand Name: ASSURE PRISM MULTI 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: 14840898
• Report Number: 1832816-2022-00005
• Device Sequence Number: 4640239
• Product Code: NBW
• UDI-Device Identifier: 00015482530501
• UDI-Public: (01)00015482530013,(01)00015482530501
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 06/28/2022
• Report Date (Section F): 06/28/2022

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: 04/20/2021
• Device Model Number: 530001
• Device Catalogue Number: 530001
• Device Lot Number: RM21MAJ5D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/20/2022
• Event Location: Home
• Date Report to Manufacturer: 06/28/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2022
• 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 Sex: Male
• Date Report Sent to FDA: 06/28/2022