MAUDE Adverse Event Report: PHILOSYS CO., LTD. GMATE; BLOOD GLUCOSE MONITORING SYSTEM

Model Number PG-301

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Hypoglycemia (1912); Sweating (2444); Shaking/Tremors (2515); Sleep Dysfunction (2517); Test Result (2695)

Event Date 04/20/2015

Event Type  malfunction  

Event Description

Patient's gmate voice home glucose meter giving extremely high false numbers, consistently 300-400s mg/dl for the last 4-5 weeks.Her basal coverage lantus insulin dose was titrated up based on these readings.Patient did report an episode of hypoglycemia that consisted of waking up sweating and shakiness.

• Brand Name: GMATE
• Type of Device: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): PHILOSYS CO., LTD.; 28-5; gwangwol-gil, okgu-eup, gunsan; jeollabuk-do, 54172 ; KS 54172
• Manufacturer (Section G): PHILOSYS CO., LTD.; 28-5; gwangwol-gil, okgu-eup, gunsan; jeollabuk-do, 54172 ; KS 54172
• Manufacturer Contact: edwards ; 900 ne 10th st.; oklahoma city, OK 73104 ; 4052712900
• MDR Report Key: 9200920
• MDR Text Key: 194773099
• Report Number: 3010172486-2019-00005
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 8705237610
• UDI-Public: 87052-37610
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Pharmacist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/20/2015,10/17/2019

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
• Device Operator: Lay User/Patient
• Device Model Number: PG-301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2015
• Distributor Facility Aware Date: 04/20/2015
• Event Location: Home
• Date Report to Manufacturer: 04/20/2015
• Initial Date Manufacturer Received: 04/20/2015
• Initial Date FDA Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 60