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

Model Number	784001
Medical Device Problem Codes	Unable to Obtain Readings (1516); High Readings (2459)
Health Effect - Clinical Codes	Hypoglycemia (1912); Convulsion/Seizure (4406)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Meter involved in incident was returned for investigation.Meter was evaluated and tested with retain strips of specified lot involved in incident.Products performed to specification.No failure detected.Meter will be forwarded to manufacturer.
Event or Problem Description
Customer called because yesterday she had a diabetic seizure.She went to the hospital, and they said the meter she has is reading too high.Her provider stated it caused her to have a diabetic seizure.She said that the meter was reading high, but her blood glucose was actually low.She explained she took a reading at night around 9:09 pm on the classic meter and received 138.She dosed herself with insulin based on the reading of 138.She went to sleep.She did not experience any symptoms at the time.The next morning, she woke up and then checked her blood sugar at 8:00 am and she did not receive a reading, the meter screen only displayed three dashes on the screen.She then started to have a seizure then became incoherent.Her mother then attempted to assist her daughter by performing a blood test using the relion premier classic meter but couldn't receive a reading.She contacted the paramedics.After the ambulance arrived, they checked her blood sugar using their meter and they received a reading of 29.The paramedics treated her with glucagon and two glucose gel packs.Replaced meter, strips, sent control solution and return label.

• Brand Name: RELION PREMIER CLASSIC BLOOD GLUCOSE 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: 16991706
• Report Number: 1832816-2023-00010
• Device Sequence Number: 15220682
• Product Code: NBW
• UDI-Device Identifier: 00681131285742
• UDI-Public: (01)00681131280624,(01)00681131285742
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/28/2023
• Report Date (Section F): 05/24/2023

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: 05/11/2024
• Device Model Number: 784001
• Device Catalogue Number: 784001
• Device Lot Number: UB06BBMJB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/28/2023
• Event Location: Home
• Date Report to Manufacturer: 05/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2023
• 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: Required Intervention; Life Threatening
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Date Report Sent to FDA: 05/24/2023