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

Model Number	GM505UCE
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6).Lot eb4031102 - 2025-05-02 - (b)(4).The customer reported receiving variable readings.The customer tested last night, and the first test was high, and the second test one hour later was low.He did not take any insulin.Customer reported that on (b)(6) 2023, his blood sugar read high at 440.He took the amount of insulin that was recommended, (b)(4) of glargine and (b)(4) of novolog, his wife was with him and heard him moaning.He rolled out of bed on the floor.His wife called the paramedics.He was passed out when they arrived.The customer passed out for about an hour.The paramedics checked his glucose, and it was 39.They treated him with meds, but he has no idea what they gave.They treated him at home.He woke up and told them he did not want to go to the hospital.Before they left, they took his blood sugar, and it was 140.He said they checked it three or four times as it was gradually getting better.It went from 80 to 140.He said he doesn't know if the problem is with the meter or him.He also mentioned he took a blood test last night and that result was 364.He did not take insulin.Two hours later, without taking insulin or medication, he stood up and he felt dizzy.He took his blood test, and the reading was 65.He has changed his diet.He lost 30 pounds.He stores the meter and strips in an unused bathroom.He is not receiving oxygen therapy.He doesn't have trouble getting a sample of blood.He changes the lancets each time he tests.He uses alcohol to clean his fingertip and allows it to dry thoroughly.Replaced meter, strips and sent return label.
Additional Manufacturer Narrative
As the complaint meter was not returned, i-sens analyzed the accuracy issue with a reference meter and retained strips from the same lot.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 three levels of capillary blood.The sd and cv of the results were below 5% and met the internal acceptance criteria, and all deviations were within 15mg/dl or % compared to the reference equipment.Therefore, we confirmed that the product is functioning properly.

• Brand Name: RELION PREMIER CLASSIC 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: 18472652
• Report Number: 3005621222-2023-00015
• Device Sequence Number: 6398899
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)00681131280624,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K192220
• 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): 01/09/2024

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: 05/02/2025
• Device Model Number: GM505UCE
• Device Catalogue Number: 784001
• Device Lot Number: EB4031102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2021
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 113 KG