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	09/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
I attach about measurement tests of the same lot-in meter as the malfunctioning meter.
Event or Problem Description
Blood glucose levels are measured too high.Customer checked the high alarm that appears when the screen is above 600 mg/dl.

• 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: 9108048
• Report Number: 3010172486-2019-00002
• Device Sequence Number: 19378393
• Product Code: NBW
• UDI-Device Identifier: 08809301160077
• UDI-Public: 8809301160077
• Combination Product (Y/N): N
• 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): 09/11/2017

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: AGE204
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/11/2017
• Device Age: 2 MO
• Event Location: Home
• Date Report to Manufacturer: 09/11/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2017
• 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