MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for QUANTIFERON?-TB GOLD TEST manufactured by Qiagen.
[183124154]
Specimen drawn for (b)(6) testing. Specimen was collected correctly in all 4 tubes, however there was no serum in the yellow and gray tubes after the sample was spun. The green and purple tubes had serum. Possible issue with the yellow and gray tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9824091 |
| MDR Report Key | 9824091 |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-31 |
| Report Date | 2020-02-12 |
| Date Reported to FDA | 2020-02-12 |
| Date Reported to Mfgr | 2020-03-12 |
| Date Added to Maude | 2020-03-12 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | QUANTIFERON?-TB GOLD TEST |
| Generic Name | TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS |
| Product Code | NCD |
| Date Received | 2020-03-12 |
| Lot Number | 1083244 (YELLOW); GRAY |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QIAGEN |
| Manufacturer Address | 19300 GERMANTOWN ROAD GERMANTOWN MD 20874 US 20874 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |