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 2014-03-27 for ADVIA CENTAUR XP 078-A010-06 manufactured by Siemens Healthcare Diagnostics Inc..
[4333715]
A discordant, (b)(6) result was obtained on one patient sample on an advia centaur xp instrument. It is unknown if the discordant result was reported to the physician(s). The sample was repeated on the same instrument and resulted (b)(6). It is unknown if the repeat result was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, (b)(6) result.
Patient Sequence No: 1, Text Type: D, B5
[11606989]
A siemens customer service engineer (cse) was dispatched to the customer site. After evaluation of the instrument, the cse discovered that the wash 1 solution and water resuspend lines were not correctly primed, which was addressed. The cse proactively replaced multiple valves and the syringe dilutor. Quality controls were run and a precision test was performed on patient samples, all of which resulted as expected. The cause of the discordant, (b)(6) result is unknown. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2014-00253 |
| MDR Report Key | 3706707 |
| Report Source | 01,05,06 |
| Date Received | 2014-03-27 |
| Date of Report | 2014-03-04 |
| Date of Event | 2014-03-03 |
| Date Mfgr Received | 2014-03-04 |
| Device Manufacturer Date | 2009-03-02 |
| Date Added to Maude | 2014-05-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD. |
| Manufacturer Street | CHAPEL LANE REGISTRATION NUMBER: 8020888 |
| Manufacturer City | DUBLIN, SWORDS |
| Manufacturer Country | EI |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | MZP |
| Date Received | 2014-03-27 |
| Model Number | ADVIA CENTAUR XP |
| Catalog Number | 078-A010-06 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-27 |