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

Model Number	GM505NAA
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2020
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 90mg/dl which was lower than standard range (n: 120~162mg/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 electrode.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 qc inspection record, it has been confirmed that the returned meter displayed normal measured value when performing a blood glucose test simulation test and passed.Thus, it is assumed that the customer did not fully understand how to test blood glucose using with product so that the customer mistakenly inserted the squared end pointing toward the device on first use.
Event or Problem Description
Customer just received a glucocard shine xl meter recently and has only received readings of 80mg/dl in the 10 tests they have done.Customer did a control solution test and this came back as 80mg/dl as well, which is outside the range on their bottle.I told customer we can replace the meter and all other products used including test strips and control solution.I explained the return process as we would like these back for testing.I also explained the shipping times and told them to call back if they do not receive it in 3-5 business days.Customer had no further questions for me.Replaced meter, strips, cs and sent rl.

• 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: 10753566
• Report Number: 3005621222-2020-00008
• Device Sequence Number: 3814254
• Product Code: NBW
• UDI-Device Identifier: 00015482540500
• UDI-Public: (01)00015482542108,(01)00015482540500
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K083468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/29/2020

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: 12/03/2021
• Device Model Number: GM505NAA
• Device Catalogue Number: 542110
• Device Lot Number: RN04PAQ7C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1