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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
Medical Device Problem Codes Computer Software Problem (1112); Application Program Problem: Dose Calculation Error (1189); Data Problem (3196)
Health Effect - Clinical Codes Hypoglycemia (1912); No Known Impact Or Consequence To Patient (2692)
Date of Event 12/08/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A patch was created in version 3.3.4.5, which was released january 3, 2018.The effected clients will be upgraded as soon as possible.
 
Event or Problem Description
After a split transition, editing the order set renders a full dose instead of second half of split dose at next basal time.
 
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Brand Name
GLUCOMMANDER
Common Device Name
PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR
Manufacturer (Section D)
GLYTEC, LLC
10 patewood drive
suite 100
greenville SC 29615
MDR Report Key7163932
Report Number3005853093-2018-00001
Device Sequence Number1979131
Product Code NDC
UDI-Device Identifier00860057000305
UDI-Public(01)00860057000305(10)3.3.2.0
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
K113853
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 01/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number3.3.2.0
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/08/2017
Initial Report FDA Received Date01/04/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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