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

Model Number	783110
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
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
(b)(6).Lot ul12bbehe - 2024-08-11 - (b)(4).The patient is receiving high readings.The patient has had meter for about three months and has just recently had an issue with it.The patient was taken to the hospital because of the readings, and they did a blood draw.The patient has not done a control solution test and walmart did not offer control solution and caller was not aware.The caller is contacting us on behalf of the patient.The patient keeps strips in the original bottle.The patient keeps meter and test strips in bedroom away from humidity and direct sunlight.The last five readings are 301, 427 at 6 am, 245 last night, 354 during day yesterday, and 422 yesterday sometime.This meter does not record the date and times of the exact readings, so i was not able to get them.The patient is not on oxygen therapy.The patient keeps strips in the original bottle and the lid closed at all times.The patient has no difficulty getting a blood sample.The patient changes lancets everyday but not always before each test.The patient tests on fingertips only and uses an alcohol wipe before each test.The patient uses the second drop of blood.Today the reading was in the 400's and they were concerned about it, so the caller took the patient to the hospital, and they took his blood and said that his sugar was not in the 400's.The patient was not experiencing any symptoms at the time.The hospital used a fingerstick and it was around 180 and then did a blood draw later and came back around 180.About 30 minutes had passed between relion compact meter reading and hospital reading.The patient only does insulin usually once per week but did take metformin based off the reading this morning of 427 and then went to the hospital.Replaced meter, strips, sent control solution and return label.

• Brand Name: RELION PREMIER COMPACT 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: 18704740
• Report Number: 1832816-2024-00004
• Device Sequence Number: 20382160
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)30681131240728,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 02/14/2024
• Report Date (Section F): 02/15/2024

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: 08/11/2024
• Device Model Number: 783110
• Device Catalogue Number: 783110
• Device Lot Number: UL12BBEHE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/23/2024
• Event Location: Home
• Date Report to Manufacturer: 02/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2024
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Date Report Sent to FDA: 02/15/2024