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

Model Number	GM505UBA
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the complaint meter was not returned, i-sens conducted an analysis of the accuracy issue using a reference meter and retained strips from the same lot.A clinical test was conducted using 40 samples, all of which met the accuracy criteria defined by iso 15197:2013.Based on these results, we confirm that the product is functioning properly.
Event or Problem Description
The customer reported that two different meters, a relion premier classic and a relion premier voice, and two different lots of premier test strips are reading too low which caused her to believe that her blood sugar was too low, so she drank orange juice to raise her blood glucose levels and ended up going to the emergency room to be treated.She stated her normal blood glucose levels are 90-100, however sometimes she receives levels in higher hundreds to lower two hundreds.She was receiving results of 50-60 testing with these products.When asked about hand cleansing, using new lancets, and blood testing techniques, she described proper blood testing techniques.When asked about control solution and testing the meter and strips with control solution to check for accuracy, she stated she does not have control solution and doesn't know what control solution is.She initially did not seek medical treatment and continued to test with each meter and test strips and continued to receive low blood glucose readings and continued to drink more orange juice based on the low blood glucose readings and eventually felt something was not right, however she was not experiencing any symptoms, but then went to the emergency room to seek medical treatment.She stated she did not treat herself with any medications or alter her medications based on the readings she received.The emergency room confirmed that her blood glucose was too high, and she was experiencing hyperglycemia.She was admitted to the hospital overnight and was treated by needing iv fluids, a double dose of insulin to lower her blood sugar level, and monitoring.Replaced meter, strips, sent control solution and return label.

• 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: 22768827
• Report Number: 3005621222-2025-00001
• Device Sequence Number: 9760201
• Product Code: NBW
• UDI-Device Identifier: 00681131169851
• UDI-Public: (01)00681131169851
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K151164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/12/2025

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 Model Number: GM505UBA
• Device Catalogue Number: 780001 / 780100
• Device Lot Number: XB16BBZRA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/28/2019
• 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: Hospitalization; Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 61 KG