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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLYTEC, LLC. GLUCOMMANDER; PREDICTIVE PULMONARY FUNCTION
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GLYTEC, LLC. GLUCOMMANDER; PREDICTIVE PULMONARY FUNCTION Back to Search Results
Model Number 3.4.1.0
Device Problems Computer Software Problem (1112); Data Problem (3196); Patient Data Problem (3197)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/10/2019
Event Type  malfunction  
Manufacturer Narrative
A patch was created in version 3.4.3.2 which was release january 12, 2019.All effected clients were upgrade by january 31, 2019.
 
Event Description
Glucommander integration with the electronic medical record (emr) may cause incorrect patient to load.On very rare instances, a system error may cause smartclick requests to overlap and identify the wrong patient for a treatment request.
 
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Brand Name
GLUCOMMANDER
Type of Device
PREDICTIVE PULMONARY FUNCTION
Manufacturer (Section D)
GLYTEC, LLC.
10 patewood drive
suite 100
greenville SC 29615
Manufacturer (Section G)
GLYTEC, LLC.
10 patewood ave
suite 100
greenville SC 29615
Manufacturer Contact
julie glendrange
10 patewood drive
suite 100
greenville, SC 29615
8642634180
MDR Report Key8293927
MDR Text Key136993653
Report Number3005853093-2019-00001
Device Sequence Number1
Product Code NDC
UDI-Device Identifier00860057000305
UDI-Public00860057000305
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 Nurse
Type of Report Initial
Report Date 01/31/2019
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
Device Operator Health Professional
Device Model Number3.4.1.0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/10/2019
Initial Date FDA Received01/31/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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