MAUDE Adverse Event Report: GLYTEC, LLC GLUCOMMANDER; PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR

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.

• Brand Name: GLUCOMMANDER
• Type of Device: PREDICTIVE 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 Key: 7630431
• MDR Text Key: 112060991
• Report Number: 3005853093-2018-00002
• Device Sequence Number: 1
• Product Code: NDC
• UDI-Device Identifier: 00860057000305
• UDI-Public: (01)00860057000305(10)3.3.4.4
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• 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 Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3.3.4.4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Weight: 104