MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-27 for SCIMEDX FTA DS8400 manufactured by Scimedx.
[658506]
Scimedx fta kit appears to have a lot of background, the controls appear to run low and there seem to be many pt's coming up as inconclusive. The problem has been reported to the vendor with no apparent improvement. I understand that there were discussions with the vendor who reported that quest diagnostics had a 50% positivity rate. This seems to cross several lot numbers and has been seen in our lab over the last year at least. Dates of use: years. Diagnosis: testing for igg antibodies against syphilus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5002859 |
| MDR Report Key | 874373 |
| Date Received | 2007-06-27 |
| Date of Report | 2007-06-26 |
| Date Added to Maude | 2007-07-11 |
| 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 |
| 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 | SCIMEDX FTA DS8400 |
| Generic Name | NONE |
| Product Code | GMQ |
| Date Received | 2007-06-27 |
| Model Number | DS8400 |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 855900 |
| Manufacturer | SCIMEDX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-27 |