MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-12-14 for GLUCOMMANDER 3.3.1.3 manufactured by Glytec, Llc.
[62377945]
Additional information around the patient was requested but not received. A patch was created in version 3. 3. 1. 3a, which was released (b)(6) 2016. The client was upgraded with the patch on (b)(6) 2016. This is the only client affected.
Patient Sequence No: 1, Text Type: N, H10
[62377946]
A health care professional reported that a patient experienced a bg of 46 mg/dl and asked that it be investigated. Upon reviewing the patient it was noted that the i:c ratio adjusted with the first bg after transition as well as adjusting twice during a "waiting to eat" meal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005853093-2016-00003 |
| MDR Report Key | 6173544 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-12-14 |
| Date of Report | 2016-12-14 |
| Date of Event | 2016-11-18 |
| Date Mfgr Received | 2016-11-23 |
| Device Manufacturer Date | 2016-03-03 |
| Date Added to Maude | 2016-12-14 |
| 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 | 3 |
| Brand Name | GLUCOMMANDER |
| Generic Name | PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR |
| Product Code | BTY |
| Date Received | 2016-12-14 |
| Model Number | 3.3.1.3 |
| 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 | 1. Required No Informationntervention | 2016-12-14 |