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

Model Number 3.3.2.0

Device Problems Computer Software Problem (1112); Application Program Problem: Dose Calculation Error (1189); Data Problem (3196)

Patient Problems Hypoglycemia (1912); No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

A patch was created in version 3.3.4.5, which was released january 3, 2018.The effected clients will be upgraded as soon as possible.

Event Description

After a split transition, editing the order set renders a full dose instead of second half of split dose at next basal time.

• Brand Name: GLUCOMMANDER
• Type of Device: PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR
• Manufacturer (Section D): GLYTEC, LLC; 10 patewood drive; suite 100; greenville SC 29615
• Manufacturer (Section G): GLYTEC, LLC; 10 patewood drive; suite 100; greenville SC 29615
• Manufacturer Contact: julie glendrange ; 10 patewood drive; suite 100; greenville, SC 29615
• MDR Report Key: 7163932
• MDR Text Key: 96829142
• Report Number: 3005853093-2018-00001
• Device Sequence Number: 1
• Product Code: NDC
• UDI-Device Identifier: 00860057000305
• UDI-Public: (01)00860057000305(10)3.3.2.0
• 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: 01/04/2018

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
• Device Operator: Health Professional
• Device Model Number: 3.3.2.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2017
• 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