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U.S. Department of Health and Human Services

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

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GLYTEC, LLC GLUCOMMANDER PREDICTIVE PULMONARY FUNCTION VALUE Back to Search Results
Model Number 3.1.0.0
Device Problems Computer Software Problem (1112); Incorrect Software Programming Calculations (1495); Device Issue (2379); Application Program Problem (2880); Device Operational Issue (2914); Programming Issue (3014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/24/2017
Event Type  malfunction  
Manufacturer Narrative
A patch was created in versions 3. 3. 1. 8 and 3. 3. 4. 2, which were released august 11, 2017. The 3 affected clients will be upgraded as soon as possible.
 
Event Description
Bedtime hypoglycemia recheck bg recommends insulin dose when it should not - following a bedtime hypoglycemia bg treated with alternative hypoglycemic treatment of 12-15 grams of carbohydrate with snacking disabled, a recheck bg recommends a snack insulin dose. There is no evidence of adverse events resulting from this bug.
 
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Brand NameGLUCOMMANDER
Type of DevicePREDICTIVE PULMONARY FUNCTION VALUE
Manufacturer (Section D)
GLYTEC, LLC
10 patewood drive, suite 100
greenville SC 29615
Manufacturer (Section G)
GLYTEC, LLC
10 patewood drive, suite 100
greenville SC 29615
Manufacturer Contact
julie glendrange
10 patewood drive, suite 100
greenville, SC 29615
8642634180
MDR Report Key6801845
MDR Text Key83153682
Report Number3005853093-2017-00001
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 08/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3.1.0.0
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 Received07/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2015
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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