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

Model Number	784001
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Headache (1880); Hypoglycemia (1912); Vomiting (2144); Chills (2191); Diaphoresis (2452)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Meter and strips involved in incident were not returned for investigation.Retain strips of specified lot were tested with qs meter and passed testing with no failures detected.If customer returns any complaint products, products will be tested and a follow-up mdr will be filed.
Event or Problem Description
Cvp10v00397.Meter was purchased in (b)(6) 2022.Lot un28bbrhf - (b)(6) 2024 - 100ct.Caller stated that meter had been giving incorrect readings and noted that the readings appeared to be of a normal level, so the patient continued with his normal routine.On the day of the incident, the patient was exhibiting symptoms of low blood sugar, so 911 was called.Because he was low, he ate some sweet foods before the paramedics arrived to get his blood sugar back up.The paramedics checked his levels with a blood glucose test, and they received a reading of 79 with their meter, but the classic meter read 115.Checked glucose readings again in the ambulance and they gave him a glucose drink to get his blood glucose level back up.The ambulance took him to the hospital for further treatment.They did lab work at the hospital.He ended up vomiting at the hospital and received further treatment until he was stable enough to go home.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: 17246126
• Report Number: 1832816-2023-00014
• Device Sequence Number: 17850276
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)00681131280624,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 06/06/2023
• Report Date (Section F): 07/03/2023

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: 12/27/2024
• Device Model Number: 784001
• Device Catalogue Number: 784001
• Device Lot Number: UN28BBRHF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/06/2023
• Event Location: Home
• Date Report to Manufacturer: 07/03/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/03/2023
• 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; Hospitalization; Life Threatening
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 136 KG
• Date Report Sent to FDA: 07/03/2023