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

Model Number 3.1.0.0

Device Problems Computer Software Problem (1112); Incorrect Software Programming Calculations (1495); Device Issue (2379); Application Program Problem (2880); Device Operational Issue (2914); Programming Issue (3014)

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

Event Date 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

A patch was created in versions 3.3.1.8 and 3.3.4.2, which were released august 11, 2017.The 3 affected clients will be upgraded as soon as possible.

Event Description

Bedtime hypoglycemia recheck bg recommends insulin dose when it should not - following a bedtime hypoglycemia bg treated with alternative hypoglycemic treatment of 12-15 grams of carbohydrate with snacking disabled, a recheck bg recommends a snack insulin dose.There is no evidence of adverse events resulting from this bug.

• Brand Name: GLUCOMMANDER
• Type of Device: PREDICTIVE PULMONARY FUNCTION VALUE
• 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 ; 8642634180
• MDR Report Key: 6801845
• MDR Text Key: 83153682
• Report Number: 3005853093-2017-00001
• Device Sequence Number: 1
• Product Code: NDC
• UDI-Device Identifier: 0086005700305
• UDI-Public: (01)0086005700305(10)3.1.0.0
• 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: Other
• Type of Report: Initial
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3.1.0.0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2017
• 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