MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-31 for GLUCOMMANDER 3.4.1.0 manufactured by Glytec, Llc..
[136993653]
A patch was created in version 3. 4. 3. 2 which was release january 12, 2019. All effected clients were upgrade by january 31, 2019.
Patient Sequence No: 1, Text Type: N, H10
[136993654]
Glucommander integration with the electronic medical record (emr) may cause incorrect patient to load. On very rare instances, a system error may cause smartclick requests to overlap and identify the wrong patient for a treatment request.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005853093-2019-00001 |
| MDR Report Key | 8293927 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-31 |
| Date of Report | 2019-01-31 |
| Date of Event | 2019-01-10 |
| Date Mfgr Received | 2019-01-10 |
| Device Manufacturer Date | 2018-07-01 |
| Date Added to Maude | 2019-01-31 |
| 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 | MRS. JULIE GLENDRANGE |
| Manufacturer Street | 10 PATEWOOD DRIVE SUITE 100 |
| Manufacturer City | GREENVILLE SC 29615 |
| Manufacturer Country | US |
| Manufacturer Postal | 29615 |
| Manufacturer Phone | 8642634180 |
| Manufacturer G1 | GLYTEC, LLC. |
| Manufacturer Street | 10 PATEWOOD AVE 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 |
| Product Code | NDC |
| Date Received | 2019-01-31 |
| Model Number | 3.4.1.0 |
| 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 | 2019-01-31 |