MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-02-24 for TB QUANTIFERON GOLD manufactured by .
[17069541]
Tb quanitferon test reported positive on the above date. Due to increase in the number of false positives with this test through quest diagnostics, it was repeated in 2009 and was reported unlikely on the second test. Diagnosis or reason for use: infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5010078 |
| MDR Report Key | 1327250 |
| Date Received | 2009-02-24 |
| Date of Report | 2009-02-24 |
| Date of Event | 2009-02-02 |
| Date Added to Maude | 2009-03-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TB QUANTIFERON GOLD |
| Generic Name | NONE |
| Product Code | GRT |
| Date Received | 2009-02-24 |
| Operator | OTHER |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-24 |