MAUDE Adverse Event Report: I-SENS, INC. GLUCOCARD SHINE XL BLOOD GLUCOSE MONITORING SYSTEM

Model Number	GM505NA
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/16/2021
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 low of 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
Caller (patient's nephew) states that his aunt has 24-hour care, so she is not testing herself, but her in-home care staff tests her blood glucose.Caller did two tests; one with the glucocard shine xl and received a reading of 98mg/dl, and one with their meter and received 309mg/dl, which made them believe the patient's meter (the glucocard shine xl) was not working correctly.Patient was alert, but caller stated she was acting somewhat erratic, so he decided to call the paramedics.Paramedics were called and when the paramedics came, they checked the patient's blood glucose with their meter and the reading was 487mg/dl.Patient was brought to the hospital.While the patient is currently still at the hospital, the caller contacted us, and we did two control solution tests with them over the phone and walked them through the steps and they received a result of 86mg/dl both times and the l1 control solution range is 115-156mg/dl.Patient's blood glucose was under control in the hospital, and she also had other medical issues that needed to be addressed.

• Brand Name: GLUCOCARD SHINE XL 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: 11676222
• Report Number: 3005621222-2021-00005
• Device Sequence Number: 3073291
• Product Code: NBW
• UDI-Device Identifier: 00015482540500
• UDI-Public: (01)00015482542108,(01)00015482540500
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083468
• 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): 04/16/2021

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: Health Professional
• Device Expiration Date: 05/27/2022
• Device Model Number: GM505NA
• Device Catalogue Number: 542110
• Device Lot Number: SA28PAS4A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/15/2021
• 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 Weight: 68