MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-23 for XTAG RESPIRATORY VIRAL PANEL manufactured by Luminex Molecular Diagnostics.
[61141577]
Reactivity for parainfluenza 2 target was reduced in xtag respiratory viral panel kit. Subsequently, while troubleshooting this issue we noticed new lots ordered as replacements displayed reduced reactivity for adenovirus and human metapneumovirus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066367 |
| MDR Report Key | 6131527 |
| Date Received | 2016-11-23 |
| Date of Report | 2016-11-23 |
| Date of Event | 2016-07-12 |
| Date Added to Maude | 2016-11-29 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | XTAG RESPIRATORY VIRAL PANEL |
| Generic Name | XTAG RESPIRATORY VIRAL PANEL |
| Product Code | OCC |
| Date Received | 2016-11-23 |
| Lot Number | MULTIPLE |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUMINEX MOLECULAR DIAGNOSTICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-23 |