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

Model Number 3.3.1.3

Device Problems Application Program Problem: Dose Calculation Error (1189); Incorrect Software Programming Calculations (1495); Programming Issue (3014)

Patient Problem Hypoglycemia (1912)

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information around the patient was requested but not received.A patch was created in version 3.3.1.3a, which was released (b)(6) 2016.The client was upgraded with the patch on (b)(6) 2016.This is the only client affected.

Event Description

A health care professional reported that a patient experienced a bg of 46 mg/dl and asked that it be investigated.Upon reviewing the patient it was noted that the i:c ratio adjusted with the first bg after transition as well as adjusting twice during a "waiting to eat" meal.

• 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: 6173544
• MDR Text Key: 62377945
• Report Number: 3005853093-2016-00003
• Device Sequence Number: 1
• Product Code: BTY
• UDI-Device Identifier: 00860057000305
• UDI-Public: (01)00860057000305(10)3.3.1.3
• 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: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3.3.1.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 72