MAUDE Adverse Event Report: I-SENS, INC. RELION PREMIER VOICE BLOOD GLUCOSE TEST SYSTEM; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number	780001
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Meter is brand new.Caller stated they received a reading of 107 and the paramedics received a reading of 25.Caller stated within the last month, rodney (patient) has been having a lot of troubles recently with his blood sugar and diabetes.When she tested him, the meter read 107, which she stated is a pretty good reading, so she didn't think he had low blood sugar, but then he started getting really combative, so she called the paramedics, and when they got there, she told them the meter read 107, but when they tested him with their meter, it read 25, indicating he was indeed having low blood sugar.Caller stated that patient often runs high on their blood glucose.Caller was unsure if the patient ate or drank anything before the incident and she stated he probably drank something, but he didn't eat anything.Caller stated she did not treat the patient based on the reading of 107 received on the premier voice meter because she did not want to give him anything because she wasn't sure what his blood glucose actually was.That is when she called the paramedics.Caller stated the patient was transferred to good (b)(6) hospital in (b)(6) caller stated incident happened early this morning (b)(6) 2023, around 12:00-12:30 am.Replaced meter, strips and sent return label.
Additional Manufacturer Narrative
Meter and strips involved in incident were not returned for investigation.Retain strips of specified lot were tested with qs meter and passed testing with no failures detected.If customer returns any complaint products, products will be tested and a follow-up mdr will be filed.
Additional Manufacturer Narrative
On 4/7/2023, products involved in incident were returned for investigation.Meter and 12 strips of specified lot were returned.On 4/12/2023, 12 returned strips were tested along with retain strips with returned meter.Meter and strips passed testing with no failures detected.Meter will be returned to the manufacturer for further investigation.

• Brand Name: RELION PREMIER VOICE 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: 16712592
• Report Number: 1832816-2023-00005
• Device Sequence Number: 20651558
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)00681131169851,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2023
• Report Date (Section F): 04/21/2023

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: Lay User/Patient
• Device Expiration Date: 08/27/2024
• Device Model Number: 780001
• Device Catalogue Number: 780001
• Device Lot Number: UL28BBHUA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/13/2023
• Event Location: Home
• Date Report to Manufacturer: 04/21/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 04/21/2023
• 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; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Date Report Sent to FDA: 04/21/2023