MAUDE Adverse Event Report: I-SENS INC. RELION PREMIER VOICE BLOOD GLUCOSE MONITORING SYSTEM

Model Number	GM505UBA
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
I-sens retrieved the complaint meter and 29t of specified strip lot and analyze the cause of higher reading.As a result of control solution test, all the results were within standard range and the cv% was below 5 which met the acceptance criteria of i-sens.However, there was inflow of foreign substance into inside of meter when it was disassembled.It is assumed that the meter functioned properly again after the foreign substance had been removed or displaced by repeated strip insertions.(b)(4).
Event or Problem Description
Customer is calling because she feels her readings are higher on the voice meter than her accu-chek meter.Verified she's had the voice meter since (b)(6) 2019.Opened test strips about two weeks ago.Stores supplies in linen closet.Customer is not receiving oxygen therapy.Doesn't have trouble getting a sample of blood.Changes lancets every time she tests.Washes hands with soap and water and allows hands to dry thoroughly.Uses fingertip as a testing site.Seals test strip bottle tightly and immediately after removing a test strip.Customer stated last night she performed a blood test on accu-chek and received 112mg/dl and then on the voice and received 167mg/dl.Customer doesn't have control solution.Explained purpose of the cs test.Customer went into explaining details about when she first noticed that the voice meter was off due to an incident that occurred last week on (b)(6) 2020.She stated on (b)(6) she took a reading at 1:30 am because she woke up due to sweating in her sleep.She received 200mg/dl on the voice meter then used her mom's accu-chek and that read 22mg/dl.She tested about one minute apart.She felt her symptoms did not match the voice meter.She stated the reading was way off.She had a 16-ounce glass of orange juice and three inches sugar in her mouth to increase her blood sugar.She stated that she was shaking and sweating.She didn't have any food or medication two hours prior.She did not contact the paramedics.Her mom treated her with a glucagon.It helped to raise her sugar levels.She went back to sleep.She woke up the next morning and she was 144mg/dl.Products have not been exposed to any extreme temperatures or humidity.

• Brand Name: RELION PREMIER VOICE BLOOD GLUCOSE MONITORING SYSTEM
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): I-SENS INC.; 43, banpo-daero, 28-gil; seocho-gu; seoul, 06646 ; KS 06646
• MDR Report Key: 9804044
• Report Number: 3005621222-2020-00003
• Device Sequence Number: 2778211
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)00681131169851,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/09/2020

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: 06/14/2021
• Device Model Number: GM505UBA
• Device Catalogue Number: 780001
• Device Lot Number: RY15BBB6J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/08/2020
• 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
• Patient Age: 65 YR
• Patient Weight: 88