MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-11-30 for GLUCOMMANDER 3.3.2.0 manufactured by Glytec, Llc.
[94200338]
A patch was created in version 3. 3. 4. 4 which was released november 10, 2017. The effected clients will be upgraded as soon as possible.
Patient Sequence No: 1, Text Type: N, H10
[94200339]
After transition, transition basal dose may not be accounted for - patient transitioning from iv to subq treatment receives transitional basal dose via "give now" selection. At start of subq treatment, prompt may be provided to give full basal again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005853093-2017-00003 |
| MDR Report Key | 7070153 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-11-30 |
| Date of Report | 2017-11-30 |
| Date of Event | 2017-11-07 |
| Date Mfgr Received | 2017-11-07 |
| Device Manufacturer Date | 2017-04-26 |
| Date Added to Maude | 2017-11-30 |
| 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 | 2017-11-30 |
| Model Number | 3.3.2.0 |
| 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 | 2017-11-30 |