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

Model Number	780001
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Meter and test strips involved in incident were returned for evaluation.Initial diagnostic testing indicated a user error finding that the strip release button had been broken.Meter was evaluated with returned strips of specified lot and performed to specification for blood testing.
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 112 and then on the voice and received 167.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 200 on the voice meter then used her mom's accu-chek and that read 22.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 144.Products have not been exposed to any extreme temperatures or humidity.Replaced meter, strips and sent rl.

• Brand Name: RELION PREMIER VOICE 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
• MDR Report Key: 9786433
• Report Number: 1832816-2020-00007
• Device Sequence Number: 16768236
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)00681131169851,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2020
• Report Date (Section F): 03/04/2020

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: 780001
• Device Catalogue Number: 780001
• Device Lot Number: RY15BBB6J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/11/2020
• Device Age: 7 MO
• Event Location: Home
• Date Report to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2020
• 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
• Date Report Sent to FDA: 03/04/2020