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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 3.3.1.3
Device Problems Application Program Problem: Dose Calculation Error (1189); Incorrect Software Programming Calculations (1495); Programming Issue (3014)
Patient Problem Hypoglycemia (1912)
Event Date 11/18/2016
Event Type  Malfunction  
Manufacturer Narrative

Additional information around the patient was requested but not received. A patch was created in version 3. 3. 1. 3a, which was released (b)(6) 2016. The client was upgraded with the patch on (b)(6) 2016. This is the only client affected.

 
Event Description

A health care professional reported that a patient experienced a bg of 46 mg/dl and asked that it be investigated. Upon reviewing the patient it was noted that the i:c ratio adjusted with the first bg after transition as well as adjusting twice during a "waiting to eat" meal.

 
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Brand NameGLUCOMMANDER
Type of DevicePREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR
Manufacturer (Section D)
GLYTEC, LLC
770 pelham road, suite 210
greenville SC 29615
Manufacturer (Section G)
GLYTEC, LLC.
770 pelham road, suite 210
greenville SC 29615
Manufacturer Contact
julie glendrange
770 pelham road, suite 210
greenville, SC 29615
8642634180
MDR Report Key6173544
MDR Text Key62377945
Report Number3005853093-2016-00003
Device Sequence Number1
Product Code BTY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK113853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 12/14/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/14/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3.3.1.3
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/23/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/03/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/14/2016 Patient Sequence Number: 1
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