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

Model Number	784001 / 780050
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer returned meter involved in the incident.The returned meter was tested with retain strips of specified lot.The meter and retain strips passed testing with no failures detected.The meter will be offered to the manufacturer for further investigation.
Event or Problem Description
The customer states that she believes the meter is not working properly because she received a high reading, treated herself, and then started feeling ill and went to the emergency room and received a much lower reading with their meter.The customer stated that within two hours prior to the incident, the customer ate a half a sandwich.The customer stated she received a reading of 251.The customer stated she took five units of insulin based on the reading of 251.The customer stated that she then started to feel weird, so she went to the emergency room.At the emergency room, with their blood glucose meter, they tested the customer and received a reading of 41 indicating the customer's blood glucose was low.They gave her graham crackers and apple juice to bring her blood sugar back up.The customer has had her meter for four or more years and stores her meter and strips in the bathroom.Advised customer we don't recommend storing in bathroom or kitchen due to humidity.The customer states she recently had valley fever and is on antibiotics for that.The customer washes and dries hands before testing, uses a new lancet, denies any damage to the meter, and occasionally has trouble getting a blood sample.Based on the incident information provided and that the customer treated herself based on the high reading which she states was incorrect, and incident report was filled out.Replaced meter, strips, sent control solution and return label.

• Brand Name: RELION PREMIER CLASSIC 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: 20641133
• Report Number: 1832816-2024-00015
• Device Sequence Number: 7506523
• Product Code: NBW
• UDI-Device Identifier: 00681131280624
• UDI-Public: (01)00681131280624
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2024
• Report Date (Section F): 11/08/2024

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: 01/05/2026
• Device Model Number: 784001 / 780050
• Device Catalogue Number: 784001 / 780050
• Device Lot Number: WD06BBKRB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2024
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/11/2024
• Event Location: Home
• Date Report to Manufacturer: 11/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2024
• 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: 33 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Date Report Sent to FDA: 11/08/2024