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

Model Number	3.4.1.0
Medical Device Problem Codes	Computer Software Problem (1112); Data Problem (3196); Patient Data Problem (3197)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A patch was created in version 3.4.3.2 which was release january 12, 2019.All effected clients were upgrade by january 31, 2019.
Event or Problem Description
Glucommander integration with the electronic medical record (emr) may cause incorrect patient to load.On very rare instances, a system error may cause smartclick requests to overlap and identify the wrong patient for a treatment request.

• Brand Name: GLUCOMMANDER
• Common Device Name: PREDICTIVE PULMONARY FUNCTION
• Manufacturer (Section D): GLYTEC, LLC.; 10 patewood drive; suite 100; greenville SC 29615
• MDR Report Key: 8293927
• Report Number: 3005853093-2019-00001
• Device Sequence Number: 1587747
• Product Code: NDC
• UDI-Device Identifier: 00860057000305
• UDI-Public: 00860057000305
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/31/2019

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: 3.4.1.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1