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

Model Number	GM01AAB
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual products were not returned for evaluation yet.Before performing evaluation on actual product, i-sens analyzed the cause of low reading with retained meter and retained strips.As a result of control solution test, all the measured values were within standard range and cv% was within the acceptance criteria (below 5%) which was satisfied to internal standard at i-sens.Thus, it is believed that the complaint device should have been functioned properly.
Event or Problem Description
Patient stated she did nothing difference on day of incident.Patient reported receiving a reading of 121mg/dl in the morning and felt the reading was not correct and had symptoms of hyperglycemia.Patient claimed she did not treat herself based on the meter reading since she was not sure what to do.Patient continued to feel unwell, so she had her neighbors call an ambulance and when they got to her, they checked her blood glucose, and it was 351mg/dl, indicating her blood glucose was high.The paramedics informed her that her meter was not working and set her up on an iv and took her to the hospital where she was treated and released later in the day.

• Brand Name: RELION PREMIER BLU 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: 11600886
• Report Number: 3005621222-2021-00003
• Device Sequence Number: 17178416
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)00681131169806,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K170614
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/01/2021

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: 09/08/2021
• Device Model Number: GM01AAB
• Device Catalogue Number: 782001
• Device Lot Number: RT09BBN5J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 04/01/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 86