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 2017-06-09 for ADVIA CENTAUR XP SYPHILIS N/A 10492493 manufactured by Siemens Healthcare Diagnostics, Inc..
[77619183]
The cause for the discordant (b)(6) results is unknown. The patient sample is not available for additional testing at the manufacturer's site. Siemens healthcare diagnostics is unable to determine root cause. The appears to be a sample specific issue. The interpretation of results section of the instructions for use (ifu) state: "results should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings. " the limitations section of the ifu states: "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. " the advia centaur syphilis (syph) ifu (10632392 rev. F, 2016-04 ous) states "the initial sensitivity of the advia centaur syph assay compared to reference assay 1 was 98. 0% (700/714) with a 95% confidence interval of 96. 7-98. 9%. The advia centaur syphilis (syph) ifu (10632391 rev. F, 2016-04 us) states "the negative percent agreement of the advia centaur syph assay compared to the comparative assay was 98. 4% (568/577) with a 95% confidence interval (ci) of 97. 1 to 99. 3%. "
Patient Sequence No: 1, Text Type: N, H10
[77619184]
Customer observed a (b)(6) advia centaur xp (b)(6) result for a sample that was (b)(6) by other methods. There are not reports that treatment was altered or prescribed or adverse health consequences due to the (b)(6) advia centaur xp (b)(6) result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2017-00140 |
| MDR Report Key | 6631081 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-09 |
| Date of Report | 2017-06-09 |
| Date of Event | 2017-05-14 |
| Date Mfgr Received | 2017-05-24 |
| Device Manufacturer Date | 2016-09-09 |
| Date Added to Maude | 2017-06-09 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LOUISE MCLAUGHLIN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604381 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST 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 |
| Generic Name | SYPHILIS ASSAY |
| Product Code | LIP |
| Date Received | 2017-06-09 |
| Model Number | N/A |
| Catalog Number | 10492493 |
| Lot Number | 11095033 |
| Device Expiration Date | 2017-09-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-06-09 |