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

Model Number	GM505UBD
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint meter and test strips were returned for analysis.As a result of control solution test with returned meter and returned strips (5t), the returned meter displayed 147, 105, 147, 68mg/dl and lo(n: 114~154mg/dl).It has been confirmed that the returned meter displayed lo and two test results were out of standard range, 105 and 68mg/dl.To analyze the cause of low reading, another control solution test was performed with returned meter and normal test strips and the returned meter displayed lo, indicating it was a meter issue.As a result of disassembling a meter, the blood was flowed into connector.
Event or Problem Description
Customer called originally to request control solution.She tried using it without the control solution and she kept receiving different error message.She tried to get solution through the local pharmacy and was advised to contact customer service.Walked customer through a test and she received lo then er4.Customer has had the meter for two weeks.Verified that she's had the meter and strips about one week.Walked customer through a proper blood test and she allowed the strip to absorb the blood sample but she received lo again.Verified she stores the meter and strips in lower level room like living room or bedroom.She has not been monitoring her diabetes and does not know what her normal glucose reading typically range.Washes hands with soap and water and allow hands to dry thoroughly.She does not have trouble receiving a sample of blood.Customer is not receiving oxygen therapy.Customer does not have symptoms to match lo.Seals bottle cap tightly and immediately after removing a test strip.

• Brand Name: RELION PREMIER CLASSIC 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: 11751238
• Report Number: 3005621222-2021-00007
• Device Sequence Number: 3527662
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)00681131280624,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K192220
• 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): 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/09/2022
• Device Model Number: GM505UBD
• Device Catalogue Number: 784001
• Device Lot Number: SS10BBHSE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1