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

Model Number	3.3.2.0
Medical Device Problem Codes	Computer Software Problem (1112); Application Program Problem: Dose Calculation Error (1189); Data Problem (3196)
Health Effect - Clinical Codes	Hypoglycemia (1912); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A patch was created in version 3.3.4.4 which was released november 10, 2017.The effected clients will be upgraded as soon as possible.
Event or Problem Description
After transition, transition basal dose may not be accounted for - patient transitioning from iv to subq treatment receives transitional basal dose via "give now" selection.At start of subq treatment, prompt may be provided to give full basal again.

• Brand Name: GLUCOMMANDER
• Common Device Name: PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR
• Manufacturer (Section D): GLYTEC, LLC; 10 patewood drive; suite 100; greenville SC 29615
• MDR Report Key: 7070153
• Report Number: 3005853093-2017-00003
• Device Sequence Number: 16379959
• Product Code: NDC
• UDI-Device Identifier: 00860057000305
• UDI-Public: (01)00860057000305(10)3.3.2.0
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/30/2017

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: 3.3.2.0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1