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 2014-12-18 for ADVIA CENTAUR XP 078-A010-01 manufactured by Siemens Healthcare Diagnostics, Inc..
[5218092]
A (b)(6) advia centaur xp (b)(6) result was obtained on a known (b)(6) patient. The same patient sample was repeated on the same advia centaur xp system and the (b)(6) result was (b)(6). The discordant result was not reported to the physician. There was no report of patient intervention or adverse health consequences due to the discordant, (b)(6) result.
Patient Sequence No: 1, Text Type: D, B5
[12707196]
The cause for the (b)(6) advia centaur xp (b)(6) result on a known (b)(6) patient is unknown. A siemens customer service engineer (cse) was dispatched to the customer site and is currently investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2014-00711 |
| MDR Report Key | 4343427 |
| Report Source | 01,05,06 |
| Date Received | 2014-12-18 |
| Date of Report | 2014-12-02 |
| Date of Event | 2014-12-02 |
| Date Mfgr Received | 2014-12-02 |
| Device Manufacturer Date | 2011-04-22 |
| Date Added to Maude | 2015-01-05 |
| 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 | MR. STEPHEN PERRY |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604163 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD. |
| Manufacturer Street | CHAPEL LANE, SWORDS, CO. REGISTRATION NUMBER 8020888 |
| Manufacturer City | DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | OBF |
| Date Received | 2014-12-18 |
| Model Number | ADVIA CENTAUR XP |
| Catalog Number | 078-A010-01 |
| ID Number | N/A |
| 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 | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-18 |