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	Low Readings (2460)
Health Effect - Clinical Code	Dehydration (1807)
Date of Event	09/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer says meter will sometimes work and sometimes not work.She said it will give er1 or er2 and sometimes read low.On (b)(6) 2022, she said her husband had taken a reading with the meter and received a reading of 32.The ambulance was called and with their meter it read 140.I asked when the ambulance came, and she said right after he got the reading of 32, she called them.They came and took his blood which read 140.I explained to the customer that because the ambulance was called, we will need to replace the meter and strips, as well as fill out an incident report, i explained i will ask a couple of questions and if she could answer them to the best that she can, that would be best.She agreed.Her husband's initials are (b)(6).Her husband is 72 years old.Her husband's date of birth is (b)(6) 1951.Her husband is not on insulin.Her husband is on metformin and water pills.No changes to diet exercise medication or stress.Her husband used to be on oxygen therapy in the past, but not recently.Patient washes and dries his hands with soap and water before lancing.Patient uses his fingertip for testing.Patient does not have trouble getting a sample of blood.Patient uses the correct method of testing.Meter and strips are stored together in the living room.Meter and strips have not been exposed to extreme temperatures.Customer said she was informed by the walmart rep about control solution for the meter.I explained we have control solution to test the meter and strips to see if they are working properly.Customer does not have control solution.I asked if there has been any damage to the meter, and she said not that she knows of.Caller did not have any symptoms at the time of the test or prior.Patient was taken to the hospital and treated and was given four bags of fluid as he was dehydrated.Replaced meter, strips and sent rl.
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 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: 15595171
• Report Number: 1832816-2022-00023
• Device Sequence Number: 19398848
• Product Code: NBW
• UDI-Device Identifier: 00681131285742
• UDI-Public: (01)00681131280624,(01)00681131285742
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/23/2022
• Report Date (Section F): 10/13/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/25/2023
• Device Model Number: 784001
• Device Catalogue Number: 784001
• Device Lot Number: TA26BBU5A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/23/2022
• Event Location: Home
• Date Report to Manufacturer: 10/13/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/13/2022
• 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; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Date Report Sent to FDA: 10/13/2022