MAUDE Adverse Event Report: PHILOSYS CO., LTD. GMATE; GMATE ORIGIN

Model Number	PG-310
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
He is taking medicine as a diabetic patient, and when he measured his blood glucose on an empty stomach using gmate origin, he found an average of 30mg/dl higher than any other product, and confirmation of the measurement deviation was requested.

• Brand Name: GMATE
• Common Device Name: GMATE ORIGIN
• Manufacturer (Section D): PHILOSYS CO., LTD.; 28-5; gwangwol-gil, okgu-eup, gunsan; jeollabuk-do, 54172 ; KS 54172
• MDR Report Key: 9108016
• Report Number: 3010172486-2019-00001
• Device Sequence Number: 16240175
• Product Code: NBW
• UDI-Device Identifier: 08809301160077
• UDI-Public: 8809301160077
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K151658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/23/2019
• Report Date (Section F): 08/17/2017

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: PG-310
• Device Catalogue Number: PG-310
• Device Lot Number: AGD204
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Report to Manufacturer: 08/17/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1