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 Code	High Readings (2459)
Health Effect - Clinical Code	Malaise (2359)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Event date: (b)(6) 2023.Aware date: (b)(6) 2023.Meter is about one year old.Caller feels that the meter is giving high readings.Customer stated she tested at home with the premier classic meter and received a reading of 356.She wasn't sure if this was correct, and she felt "weird", so her sister took her to the er, and they tested her with their meter and received a reading of 190.Customer reported the following readings in her meter memory.222 - (b)(6) 2023 at 1:01 pm; 258 - (b)(6) 2023 at 12:47 pm; 269 - 4/4/2023 at 10:21 pm.Caller acknowledged that the date and time are off on the meter.Customer could not find the reading of 356 in her meter memory during the call.Customer did not treat herself based on the reading 356 and wasn't sure if it was correct, so that is why her sister took her to the er.The only treatment the er provided her with was that they gave her fluids and discharged her.Customer states that when she got home from the er, about 3-5 minutes' drive time later, she tested again with her meter and 352, and this is also unverifiable due to the date and time being off in the meter and customer not being able to find it in the meter memory.Customer doesn't trust meter and would like a replacement sent.Replaced meter, strips, sent cs and return label.
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.

• 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: 16974508
• Report Number: 1832816-2023-00011
• Device Sequence Number: 2453148
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)00681131280624,(01)00681131169776
• 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: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2023
• Report Date (Section F): 05/22/2023

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: 09/29/2024
• Device Model Number: 784001
• Device Catalogue Number: 784001
• Device Lot Number: UT31BBKZA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/03/2023
• Event Location: Home
• Date Report to Manufacturer: 05/22/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2023
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Date Report Sent to FDA: 05/22/2023