MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-22 for GLUCOMMANDER 3.3.4.4 manufactured by Glytec, Llc.
[112060991]
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.
Patient Sequence No: 1, Text Type: N, H10
[112060992]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005853093-2018-00002 |
| MDR Report Key | 7630431 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-22 |
| Date of Report | 2018-06-22 |
| Date of Event | 2018-05-31 |
| Date Mfgr Received | 2018-05-31 |
| Device Manufacturer Date | 2017-04-26 |
| Date Added to Maude | 2018-06-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JULIE GLENDRANGE |
| Manufacturer Street | 10 PATEWOOD DRIVE SUITE 100 |
| Manufacturer City | GREENVILLE SC 29615 |
| Manufacturer Country | US |
| Manufacturer Postal | 29615 |
| Manufacturer G1 | GLYTEC, LLC |
| Manufacturer Street | 10 PATEWOOD DRIVE SUITE 100 |
| Manufacturer City | GREENVILLE SC 29615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLUCOMMANDER |
| Generic Name | PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR |
| Product Code | NDC |
| Date Received | 2018-06-22 |
| Model Number | 3.3.4.4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLYTEC, LLC |
| Manufacturer Address | 10 PATEWOOD DRIVE SUITE 100 GREENVILLE SC 29615 US 29615 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-06-22 |