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

Model Number	3.3.1.3
Medical Device Problem Codes	Application Program Problem: Dose Calculation Error (1189); Incorrect Software Programming Calculations (1495); Programming Issue (3014)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	11/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information around the patient was requested but not received.A patch was created in version 3.3.1.3a, which was released (b)(6) 2016.The client was upgraded with the patch on (b)(6) 2016.This is the only client affected.
Event or Problem Description
A health care professional reported that a patient experienced a bg of 46 mg/dl and asked that it be investigated.Upon reviewing the patient it was noted that the i:c ratio adjusted with the first bg after transition as well as adjusting twice during a "waiting to eat" meal.

• 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: 6173544
• Report Number: 3005853093-2016-00003
• Device Sequence Number: 426481
• Product Code: BTY
• UDI-Device Identifier: 00860057000305
• UDI-Public: (01)00860057000305(10)3.3.1.3
• 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): 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3.3.1.3
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2016
• Initial Report FDA Received Date: 12/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 72