MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-24 for CRAG LFA manufactured by Immy.
[73804611]
Patient had blood test for cryptococcosis with false positive results due to assay malfunction. Therapy start date: (b)(6) 2016. Diagnosis or reason for use: cryptococcosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069311 |
| MDR Report Key | 6521790 |
| Date Received | 2017-04-24 |
| Date of Report | 2017-04-24 |
| Date of Event | 2016-11-17 |
| Date Added to Maude | 2017-04-26 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CRAG LFA |
| Generic Name | CRAG LFA |
| Product Code | GMD |
| Date Received | 2017-04-24 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMY |
| Manufacturer Address | 2701 CORPORATE CENTER DRIVE NORMAN OK 73069 US 73069 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-24 |