MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-20 for LANTUS SOLOSTAR PEN 3ML 5'S; 100U manufactured by Aventis.
[18496663]
Dose knob either won't turn or won't go down. Trying a new pen needle dose to resolve the issue. Dose, frequency and route used: 24 units sc daily. Therapy dates: 4 years.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022813 |
| MDR Report Key | 2310338 |
| Date Received | 2011-10-20 |
| Date of Report | 2011-10-13 |
| Date of Event | 2011-10-13 |
| Date Added to Maude | 2011-10-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LANTUS SOLOSTAR PEN 3ML 5'S; 100U |
| Generic Name | NONE |
| Product Code | KZE |
| Date Received | 2011-10-20 |
| Lot Number | 1F66A |
| ID Number | 00088 2219 05 |
| Device Expiration Date | 2012-08-03 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVENTIS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-20 |