MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-12-30 for ADVIA CENTAUR XP SYPHILIS (SYPH) ASSAY N/A 10492493 manufactured by Siemens Healthcare Diagnostics, Inc..
[5267045]
False negative advia centaur xp syphilis (syph) results were obtained for a patient sample during validation. The patient sample was tested on the immulite 2000 and the result was reactive. The patient sample was tested on the fta-abs blood test (confirmatory test). The test resulted in positive for igg and negative for igm. It is unknown if patient treatment was altered or prescribed. There was no report of adverse health consequences due to the discordant advia centaur xp syphilis results.
Patient Sequence No: 1, Text Type: D, B5
[12724410]
The customer declined service as there were no issues with the other assays on the system. The cause for the discordant syphilis (syph) results is unknown. The instrument is performing within specifications. No further evaluation of the device is required. The ifu states in the limitations section: "a nonreactive test result does not exclude the possibility of exposure to or infection with syphilis. T. Pallidum antibodies may be undetectable in some stages of the infection and in some clinical conditions. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2014-00311 |
| MDR Report Key | 4369798 |
| Report Source | 01,05,06 |
| Date Received | 2014-12-30 |
| Date of Report | 2014-12-11 |
| Date of Event | 2014-11-27 |
| Date Mfgr Received | 2014-12-11 |
| Device Manufacturer Date | 2014-01-27 |
| Date Added to Maude | 2015-01-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. EIMAN SULIEMAN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604603 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP SYPHILIS (SYPH) ASSAY |
| Generic Name | SYPHILIS ASSAY |
| Product Code | LIP |
| Date Received | 2014-12-30 |
| Model Number | N/A |
| Catalog Number | 10492493 |
| Lot Number | 017 AND 018 |
| ID Number | N/A |
| Device Expiration Date | 2015-01-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-30 |