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	Hypoglycemia (1912)
Date of Event	03/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint products were not returned for evaluation.Retain strips of specified lot were tested with reference meter and passed testing with no failures detected.If either meter or strips is returned, arkray will evaluate the product and file a follow-up report.
Event or Problem Description
Patient has had the premier compact for a year.The meter serial number is rubbed off.Patient stated they received a reading of 231.Because of this higher reading, the patient treated himself with insulin and then went too low and fainted and became unconscious.The paramedics were called.When the paramedics took a few readings, their meters read 20 when testing the patient indicating that his blood sugar was extremely low.Patient was treated by the paramedics who gave him glucose to get back to a stable level.Patient was not transferred to a hospital and felt better after being treated by the paramedics.Patient is concerned that the reading of 231 was most likely inaccurate and his blood sugar wasn't high at the time of that test, because he didn't have any symptoms and felt fine, but then treated himself inappropriately based on the reading of 231.Patient is now unsure if the readings he is receiving are accurate.Patient had tested with control solution a month ago and the reading was in range, but the caller no longer has control solution to test the meter again at this time.Replaced meter, strips, sent control solution and return label.
Additional Manufacturer Narrative
Customer returned meter.During initial diagnostic testing, it was observed that the print was rubbed of the label of the meter.It was also observed that there were two dent spots on the back casing of the meter.During meter download, it was observed that the serial number of the meter is (b)(6).The returned meter was tested with retain strips of specified lot and passed blood testing.Meter will be returned to the manufacturer for further investigation.This follow-up report is delayed because the original mdr was submitted incorrectly, and we needed to wait for the fda to delete the incorrect report to submit the corrected report.Please see the attached correspondence with the fda for more information.
Event or Problem Description
Patient has had the premier compact for a year.The meter serial number is rubbed off.Patient stated they received a reading of 231.Because of this higher reading, the patient treated himself with insulin and then went too low and fainted and became unconscious.The paramedics were called.When the paramedics took a few readings, their meters read 20 when testing the patient indicating that his blood sugar was extremely low.Patient was treated by the paramedics who gave him glucose to get back to a stable level.Patient was not transferred to a hospital and felt better after being treated by the paramedics.Patient is concerned that the reading of 231 was most likely inaccurate and his blood sugar wasn't high at the time of that test, because he didn't have any symptoms and felt fine, but then treated himself inappropriately based on the reading of 231.Patient is now unsure if the readings he is receiving are accurate.Patient had tested with control solution a month ago and the reading was in range, but the caller no longer has control solution to test the meter again at this time.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: 11798435
• Report Number: 1832816-2021-00006
• Device Sequence Number: 3869584
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)30681131240728,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021
• Report Date (Section F): 03/27/2021

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: 10/16/2022
• Device Model Number: 783110
• Device Catalogue Number: 783110
• Device Lot Number: SS17BBJ9A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/13/2021
• Event Location: Home
• Date Report to Manufacturer: 03/27/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 05/11/2021
• 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: 52 YR
• Patient Weight: 70
• Date Report Sent to FDA: 03/27/2021