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	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The result of control solution test, with returned meter and normal strip, was 98mg/dl which was lower than standard range(h: 198~267mg/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.As reviewing in-process inspection record and qc data of complaint meter, it has been confirmed that the returned meter properly displayed measured value (approximately glucose concentration of 200mg/dl) and passed qc inspection.Thus, it is assumed that the user accidently inserted test strip with the edge to apply blood facing upwards and it caused of counter pin deformation.For returned test strips, the appearance looked normal comparing with normal test strips.However, the results of control solution test with normal meter were very low even though they were within standard range except one, 116, 116, 115, 113 and 116mg/dl(n: 114~155mg/dl).To analyze the cause, we performed another control solution test with same lot of retained test strips and all results were within standard range.As reviewing the corresponding lot of dhr, it has been confirmed that enzyme was properly dispensed on bottom sheet and they passed vision inspection.Thus, it is assumed that the returned test strips were contaminated with foreign liquid substance during use.
Event or Problem Description
Customer called to know how to perform a control solution test.We did the test together on his solution that he just opened.The reading was 78mg/dl which was below the range.

• 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: 11573618
• Report Number: 3005621222-2021-00002
• Device Sequence Number: 11850189
• Product Code: NBW
• UDI-Device Identifier: 00015482540500
• UDI-Public: (01)00015482540012,(01)00015482540500
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/26/2021

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: 01/05/2022
• Device Model Number: GM505WAA
• Device Catalogue Number: 541100
• Device Lot Number: RD06PAR3B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1