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

Model Number	GM505NAA
Medical Device Problem Codes	Incorrect Measurement (1383); Low Readings (2460); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
I-sens retrieved the complaint meter and analyzed the cause of incorrect reading.The result of control solution test, with returned meter and normal strip, was 84mg/dl which was lower than standard range (n: 116~174mg/dl).As a result of disassembling a meter, the counter pin was displaced and it caused of contact failure with connector pin and test strip.In the memory, there were 68 data saved so it should have been displaced during use.When the connector pin is displaced or foreign substance is flowed into the connector, the contact between meter's connector and strip is unstable.It will affect electrical current and may be resulted in low reading.
Event or Problem Description
Customer is not receiving any oxygen therapy.Customer doesn't have trouble getting a sample of blood.Customer doesn't change her lancets every time she tests.She changed lancets once or twice a week.Stores in her bedroom.Washes hands with soap and water and alcohol.Allows hands to dry thoroughly.Uses fingertip as a testing site.Received 126mg/dl and 76mg/dl which is a 39% variance.Walked customer through a control solution test and it tested ouside the range.Cs reading is 79mg/dl in l1 range of 114-154mg/dl.

• 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: 10377599
• Report Number: 3005621222-2020-00006
• Device Sequence Number: 1730184
• Product Code: NBW
• UDI-Device Identifier: 00015482540500
• UDI-Public: (01)00015482542108,(01)00015482540500
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/07/2020

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: 09/06/2021
• Device Model Number: GM505NAA
• Device Catalogue Number: 542110
• Device Lot Number: RT07PAP3A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1