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

Model Number	3.2
Medical Device Problem Codes	Computer Software Problem (1112); Incorrect Software Programming Calculations (1495); Application Program Problem (2880)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2016
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR
• Manufacturer (Section D): GLYTEC, LLC; 770 pelham road, suite 210; greenville SC 29615
• MDR Report Key: 5967144
• Report Number: 3005853093-2016-00002
• Device Sequence Number: 11141693
• Product Code: BTY
• UDI-Device Identifier: 00860057000305
• UDI-Public: (01)00860057000305(10)3.2
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K113853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2016

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
• Operator of Device: Health Professional
• Device Model Number: 3.2
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2016
• Initial Report FDA Received Date: 09/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1