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

Model Number	GM505WAA
Medical Device Problem Codes	Incorrect Measurement (1383); Low Readings (2460)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2020
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 86mg/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
Caller has owned meter for two weeks.Customer says she keeps receiving the same number when she perform a blood test.I asked her to insert a new strip into meter while meter is off and meter powered on with the flashing drop.I asked her if she would like to perform a blood test with me and she said yes.I asked her to perform her finger poke and get the blood ready but not to do anything else.Then explained she wants to hold meter so that strip is pointing to the floor then to hold strip end in the blood for three seconds without touching the skin.She did so and received a reading of 89mg/dl.She says she keeps getting that number even though she does not feel like it.I asked where she stores meter and strips and she says near the kitchen on the counter top.

• 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: 10377602
• Report Number: 3005621222-2020-00005
• Device Sequence Number: 1730185
• Product Code: NBW
• UDI-Device Identifier: 00015482540500
• UDI-Public: (01)00015482540012,(01)00015482540500
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120351
• 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: 11/01/2021
• Device Model Number: GM505WAA
• Device Catalogue Number: 541100
• Device Lot Number: RB02PAQ3Q
• 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