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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 3.3.2.0
Device Problems Computer Software Problem (1112); Application Program Problem: Dose Calculation Error (1189); Data Problem (3196)
Patient Problems Hypoglycemia (1912); No Known Impact Or Consequence To Patient (2692)
Event Date 11/07/2017
Event Type  malfunction  
Manufacturer Narrative
A patch was created in version 3. 3. 4. 4 which was released november 10, 2017. The effected clients will be upgraded as soon as possible.
 
Event Description
After transition, transition basal dose may not be accounted for - patient transitioning from iv to subq treatment receives transitional basal dose via "give now" selection. At start of subq treatment, prompt may be provided to give full basal again.
 
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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, LLC
10 patewood drive
suite 100
greenville SC 29615
Manufacturer Contact
julie glendrange
10 patewood drive
suite 100
greenville, SC 29615
MDR Report Key7070153
MDR Text Key94200338
Report Number3005853093-2017-00003
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 11/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3.3.2.0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/26/2017
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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