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	03/28/2018
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
When blood glucose values were simultaneously measured using gmate voice and gmate origin, the difference in blood glucose readings between the two devices was more than 40 mg/dl.(the result of gmate origin is measured higher.).

• 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: 9127122
• Report Number: 3010172486-2019-00004
• Device Sequence Number: 2388562
• 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): 09/24/2019
• Report Date (Section F): 03/28/2018

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: No Information
• Device Model Number: PG-310
• Device Catalogue Number: PG-310
• Device Lot Number: AGF201
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 1 MO
• Event Location: Home
• Date Report to Manufacturer: 03/28/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1