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

Model Number	GM505WAA
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
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 83mg/dl which was lower than standard range (n: 118~159mg/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.For counter pin, it can be displaced if the test strip inserted the squared end pointing toward the device.When the connector pin is displaced, the contact between meter's connector and strip is unstable.It will affect electrical current and may be resulted in low reading.As reviewing corresponding meter's inspection record, it has been confirmed that the returned meter displayed normal measured value when performing a blood glucose test simulation and passed inspection.Thus, it is assumed that the customer did not fully understand how to perform a blood glucose test using with product so that she accidently inserted the squared end pointing toward the device.
Event or Problem Description
The customer was worried about the accuracy of her glucocard shine meter and performed control solution tests with two different bottles of test strips.She had perfect technique for performing the control solution testing; however, the level one control solution tests were on average 20 points below the range on both bottles of test strips.Level 1 range listed on both bottles of test strips is 118-159mg/dl, but reading on both bottles of test strips are low at 85-95mg/dl.

• Brand Name: GLUCOCARD SHINE 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: 11431985
• Report Number: 3005621222-2021-00001
• Device Sequence Number: 3117385
• Product Code: NBW
• UDI-Device Identifier: 00015482540012
• UDI-Public: (01)00015482540012
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K120351
• 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): 03/08/2021

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 Model Number: GM505WAA
• Device Catalogue Number: 541100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1