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

Model Number	3.3.4.4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hypoglycemia (1912); Seizures (2063)
Date of Event	05/31/2018
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR
• Manufacturer (Section D): GLYTEC, LLC; 10 patewood drive; suite 100; greenville SC 29615
• MDR Report Key: 7630431
• Report Number: 3005853093-2018-00002
• Device Sequence Number: 2435574
• Product Code: NDC
• UDI-Device Identifier: 00860057000305
• UDI-Public: (01)00860057000305(10)3.3.4.4
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152300
• Number of Events Summarized: 1
• 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): 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 3.3.4.4
• 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: 05/31/2018
• Initial Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 74 YR
• Patient Weight: 104