MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-21 for GLUCOMMANDER 3.2 manufactured by Glytec, Llc.
[55677419]
Glytec discovered a software error in the glucommander application that affected basal dosing recommendations when edited using twice daily dosing. After the edit is performed the basal dose recommendation adjusts incorrectly. There is no indication that the product caused or contributed to an adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005853093-2016-00002 |
| MDR Report Key | 5967144 |
| Date Received | 2016-09-21 |
| Date of Report | 2016-09-21 |
| Date of Event | 2016-08-24 |
| Date Mfgr Received | 2016-08-24 |
| Device Manufacturer Date | 2016-03-03 |
| Date Added to Maude | 2016-09-21 |
| 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 | 770 PELHAM ROAD, SUITE 210 |
| Manufacturer City | GREENVILLE SC 29615 |
| Manufacturer Country | US |
| Manufacturer Postal | 29615 |
| Manufacturer Phone | 8642634180 |
| Manufacturer G1 | GLYTEC, LLC. |
| Manufacturer Street | 770 PELHAM ROAD, SUITE 210 |
| 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 | 0 |
| Brand Name | GLUCOMMANDER |
| Generic Name | PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR |
| Product Code | BTY |
| Date Received | 2016-09-21 |
| Model Number | 3.2 |
| 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 | 770 PELHAM ROAD, SUITE 210 GREENVILLE SC 29615 US 29615 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-21 |