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

Model Number 3.3.1.5

Device Problems Application Program Problem: Parameter Calculation Error (1449); Incorrect Software Programming Calculations (1495); Programming Issue (3014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

A patch was created in versions 3.3.4.3 and 3.3.1.9, which were released (b)(6) 2017.The effected clients will be upgraded as soon as possible.

Event Description

Basal dose charted in future; administered basal dose, on an intermittent rare occasion can be recorded for the correct day and month, but for year 2020 instead of year dose was given.After future entry no basal dose is calculated.There is no evidence of adverse events resulting from this bug.

• Brand Name: GLUCOMMANDER
• Type of Device: PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR
• Manufacturer (Section D): GLYTEC, LLC.; 10 patewood drive, suite 100; greenville SC 29615
• Manufacturer (Section G): GLYTEC; 10 patewood drive, suite 100; greenville SC 29615
• Manufacturer Contact: julie glendrange ; 10 patewood drive, suite 100; greenville, SC 29615 ; 8642634180
• MDR Report Key: 6884024
• MDR Text Key: 89375600
• Report Number: 3005853093-2017-00002
• Device Sequence Number: 1
• Product Code: NDC
• UDI-Device Identifier: 0086005700305
• UDI-Public: (01)0086005700305(10)3.3.1.5
• 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: Other
• Type of Report: Initial
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3.3.1.5
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2017
• 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