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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLYTEC, LLC. GLUCOMMANDER PREDECTIVE PULMONARY FUNCTION

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GLYTEC, LLC. GLUCOMMANDER PREDECTIVE PULMONARY FUNCTION Back to Search Results
Model Number 3.4.2.2
Device Problems Decoupling (1145); Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/09/2019
Event Type  malfunction  
Manufacturer Narrative
The interruption and the data anomalies were determined not to be caused by glucommander.
 
Event Description
Glucommander experienced an interruption in the flow of data from an external glucose data source for a brief period of time. Once connection was re-established, data anomalies were observed. Before the anomalies were corrected, dose recommendations were generated for six (6) patients. The anomalies had no impact on the appropriateness of the dose recommendations; therefore, there was no risk to these patients.
 
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Brand NameGLUCOMMANDER
Type of DevicePREDECTIVE PULMONARY FUNCTION
Manufacturer (Section D)
GLYTEC, LLC.
10 patewood drive
suite 100
greenville SC 29615
Manufacturer Contact
robert booth
10 patewood drive
suite 100
greenville, SC 29615
8642634165
MDR Report Key8766020
MDR Text Key150259951
Report Number3005853093-2019-00002
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 07/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3.4.2.2
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 Received06/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2018
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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