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U.S. Department of Health and Human Services

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

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GLYTEC, LLC. GLUCOMMANDER PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR Back to Search Results
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.
 
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Brand NameGLUCOMMANDER
Type of DevicePREDICTIVE 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 Key6884024
MDR Text Key89375600
Report Number3005853093-2017-00002
Device Sequence Number1
Product Code NDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 09/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3.3.1.5
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/03/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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