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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 3.3.4.4
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Hypoglycemia (1912); Seizures (2063)
Event Date 05/31/2018
Event Type  Death  
Manufacturer Narrative
According to customer reports, the final three bgs were taken from a peripherally inserted central catheter (picc) which had dextrose infusing through one of the ports and the contaminated samples resulted in falsely elevated poc blood glucose measurements. Application audit logs for this patient treatment were reviewed, encompassing components such as settings and configuration, sensitivity factor adjustments, insulin infusion rate recommendations, warnings and alerts. A simulation case was also evaluated in a test environment and produced identical results. After careful review and diagnostic testing, it was determined that the application performed within specifications and no product non-conformances were identified.
 
Event Description
The customer reported that a critically ill hospitalized patient, was started on glucommander iv. The patient reached target range and remained in target for approximately 8 hours, upon which a blood glucose of 292 mg/dl was entered by the nurse. Because of the dramatic change in blood glucose levels, glucommander presented a warning to the end user alerting them that this blood glucose was significantly higher than the previous blood glucose and asking them to confirm the blood glucose was 292 mg/dl. The user acknowledged the warning and confirmed the bg at 292 mg/dl. A subsequent bg of 315 mg/dl was entered next, upon which glucommander alerted the user that the maximum infusion rate had been reached and to contact the physician. A final bg of 257 mg/dl was entered 67 minutes later, 7 minutes past the recommended bg check time. After this final bg was entered, the customer stated the patient had seizures and a subsequent bg reading showed severe hypoglycemia which was not entered into glucommander.
 
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Brand NameGLUCOMMANDER
Type of DevicePREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR
Manufacturer (Section D)
GLYTEC, LLC
10 patewood drive
suite 100
greenville SC 29615
Manufacturer (Section G)
GLYTEC, LLC
10 patewood drive
suite 100
greenville SC 29615
Manufacturer Contact
julie glendrange
10 patewood drive
suite 100
greenville, SC 29615
MDR Report Key7630431
MDR Text Key112060991
Report Number3005853093-2018-00002
Device Sequence Number1
Product Code NDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 06/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3.3.4.4
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/26/2017
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: 06/22/2018 Patient Sequence Number: 1
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