MAUDE Adverse Event Report: I-SENS RELION PREMIER VOICE BLOOD GLUCOSE TEST SYSTEM; BLOOD GLUCOSE MONITORING SYSTEM

Model Number	GM505UDF
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Hypoglycemia (1912); Dizziness (2194)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the complaint meter was not returned, i-sens analyzed the accuracy issue with a retained meter and strips from the same lot.As a result of the control solution test, all results were within the standard range, and the cv% was within the acceptance criteria (below 5%), which satisfied the internal standard in i-sens.Therefore, it is judged that the product operated normally.
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 samaritan hospital in kearney, ne.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
Before the complaint products were returned, i-sens conducted control solution tests using reference meter and retained strips of the complaint lot.As a result, all readings met the acceptable criteria.After the complaint meter was returned, i-sens conducted control solution and blood tests using the returned meters and retained strips.Firstly, as a result of the control solution test, all results satisfied the acceptable range in both a and b levels.Secondly, the test was conducted using capillary blood with a concentration similar to the customer's blood glucose level at the time of the issue.The sd of the results was below 5 and met the internal acceptance criteria, and all deviations were within 15mg/dl compared to the reference equipment.Therefore, we confirmed that the product is functioning properly.

• Brand Name: RELION PREMIER VOICE BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): I-SENS; 43, banpo-daero 28-gil; seocho-gu; seoul, 06646 ; KS 06646
• Manufacturer (Section G): I-SENS WONJU FACTORY; 94-1, donghwagongdan-ro; munmak-eup; wonju-si, 26365 ; KS 26365
• Manufacturer Contact: hyojin baik ; 43, banpo-daero 28-gil; seocho-gu; seoul, 06646 ; KS 06646
• MDR Report Key: 16730154
• Report Number: 3005621222-2023-00004
• Device Sequence Number: 20501673
• 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
• PMA/510(K) Number: K121133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2023

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: GM505UDF
• Device Catalogue Number: 780001
• Device Lot Number: UL28BBHUA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 59 KG