MAUDE Adverse Event Report: GLYTEC, LLC GLUCOMMANDER; PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR

Model Number 3.1

Device Problems Computer Software Problem (1112); Incorrect Software Programming Calculations (1495); Application Program Problem (2880)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2016

Event Type  malfunction  

Manufacturer Narrative

This report is late due to difficulties and delays getting the emdr system set up and registered.

Event Description

Glytec discovered a software error in the glucommander application that affected time processing in the hours prior to the change from standard time to daylight savings time.The error corrected after 2am local time.

• Brand Name: GLUCOMMANDER
• Type of Device: PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR
• Manufacturer (Section D): GLYTEC, LLC; 770 pelham road, suite 210; greenville SC 29615
• Manufacturer (Section G): GLYTEC, LLC.; 770 pelham road, suite 210; greenville SC 29615
• Manufacturer Contact: julie glendrange ; 770 pelham road, suite 210; greenville, SC 29615 ; 8642634180
• MDR Report Key: 5596048
• MDR Text Key: 44183057
• Report Number: 3005853093-2016-00001
• Device Sequence Number: 1
• Product Code: NDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/21/2016

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: Health Professional
• Device Model Number: 3.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2016
• Initial Date FDA Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1