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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 3.2
Device Problems Computer Software Problem; Incorrect Software Programming Calculations; Application Program Problem
Event Date 08/24/2016
Event Type  Malfunction  
Event Description

Glytec discovered a software error in the glucommander application that affected basal dosing recommendations when edited using twice daily dosing. After the edit is performed the basal dose recommendation adjusts incorrectly. There is no indication that the product caused or contributed to an adverse event.

 
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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 Key5967144
Report Number3005853093-2016-00002
Device Sequence Number1
Product CodeBTY
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 09/21/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/21/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3.2
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 Received08/24/2016
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

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