MAUDE Adverse Event Report: I-SENS RELION¿ PREMIER COMPACT BLOOD GLUCOSE MONITORING SYSTEM

Model Number	783110
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Hypoglycemia (1912); Dizziness (2194); Ambulation or Postural Difficulties (2544)
Date of Event	10/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the complaint meter was not returned, i-sens analyzed the accuracy issue with the reference meter and retained strips from the complaint lot.Firstly, as a result of the control solution test, all results satisfied the acceptable range in both a and b levels.Secondly, the tests were conducted with three types of blood with glucose concentrations adjusted to low, medium, and high concentrations.As a result, all readings satisfied 15 mg/dl or % compared to the standard equipment, and sd and cv also satisfied the acceptable range.Therefore, we confirmed that the product is functioning properly.
Event or Problem Description
The patient had lunch at about 12:00 pm.The caller stated that she tested her nephew about two hours later and received a reading of 400 with this meter, and then received another reading of what she thinks was 600 with this meter.The caller treated the patient based on these readings with novolog which is his fast-acting insulin.She used the same blood drop for all tests.After about 45 minutes, the patient then started displaying symptoms, such as he could not walk and was lightheaded and dizzy.The caller did not take the patient to the er or call the paramedics and just treated him at home.She gave him some orange juice, glucose tablets, and a coke to bring his blood sugar back up.The caller would like to switch to the classic meter because it has a memory and date/time stamp for the results.Replaced meter, strips and sent return label.

• Brand Name: RELION¿ PREMIER COMPACT BLOOD GLUCOSE MONITORING SYSTEM
• Common Device Name: 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: 20794703
• Report Number: 3005621222-2024-00013
• Device Sequence Number: 17866198
• Product Code: NBW
• UDI-Device Identifier: 00681131240727
• UDI-Public: (01)00681131240727
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 11/27/2024

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 Model Number: 783110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2024
• 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; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 149 KG