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

Model Number 3.2

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 08/24/2016

Event Type  malfunction  

Event Description

Glytec discovered a software error in the glucommander application that affected basal dosing recommendations when edited using twice daily dosing.After the edit is performed the basal dose recommendation adjusts incorrectly.There is no indication that the product caused or contributed to an adverse event.

• 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: 5967144
• MDR Text Key: 55677419
• Report Number: 3005853093-2016-00002
• Device Sequence Number: 1
• Product Code: BTY
• UDI-Device Identifier: 00860057000305
• UDI-Public: (01)00860057000305(10)3.2
• 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: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2016
• 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