MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-04-28 for ADVIA CENTAUR XP SYPHILIS (SYPH) N/A 10492493 manufactured by Siemens Healthcare Diagnostics, Inc..
[74067536]
The cause for the discordant (b)(6) results is unknown. The patient sample is not available for additional testing at the manufacturer's site due to (b)(6) customs regulations. Siemens healthcare diagnostics is investigating. The ifu states in the interpretation of results section: "results should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings. " 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. Assay performance characteristics have not been established when the advia centaur syph assay is used in conjunction with other manufacturers' assays for specific syphilis serological markers. "
Patient Sequence No: 1, Text Type: N, H10
[74067537]
A (b)(6) advia centaur xp (b)(6) result was obtained for a patient sample. The patient sample was tested on three alternate methods and the results were reactive. A previous sample from the same patients was tested in (b)(6) 2016. The results were (b)(6) on the advia centaur xp (b)(6) assay and (b)(6) on the three alternate methods. The patient was considered (b)(6) for (b)(6) testing. The patient sample was tested at another laboratory on the advia centaur xp (b)(6) assay and the results were (b)(6). Patient treatment was not altered or prescribed. There was no report of adverse health consequences due to the discordant advia centaur xp (b)(6) results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2017-00118 |
| MDR Report Key | 6529737 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-28 |
| Date of Report | 2017-08-01 |
| Date of Event | 2017-03-19 |
| Date Mfgr Received | 2017-07-31 |
| Device Manufacturer Date | 2016-04-27 |
| Date Added to Maude | 2017-04-28 |
| 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 | 3 |
| Event Location | 3 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP SYPHILIS (SYPH) |
| Generic Name | SYPHILIS ASSAY |
| Product Code | LIP |
| Date Received | 2017-04-28 |
| Model Number | N/A |
| Catalog Number | 10492493 |
| Lot Number | 39081030 |
| Device Expiration Date | 2017-04-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-28 |