MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-10-27 for ADVIA CENTAUR XP 078-A010-XX manufactured by Siemens Healthcare Diagnostics.
[1303203]
A discordant advia centaur xp carbamezapine result was obtained on a pt sample. The result was not reported to the physician(s). The sample was retested neat and with dilution and the corrected result was reported. There was no report of pt intervention or adverse health consequences due to the discordant carbamezapine result.
Patient Sequence No: 1, Text Type: D, B5
[8364564]
A siemens field service engineer (fse) was dispatched to the customer site. Analysis of the instrument and instrument data indicated that the cause of the discordant carbamezapine result was due to a broken connector on the acid pump. The instrument was repaired. The instrument is performing within specs. No further eval of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2009-00197 |
| MDR Report Key | 1521671 |
| Report Source | 05,06 |
| Date Received | 2009-10-27 |
| Date of Report | 2009-10-06 |
| Date of Event | 2009-10-05 |
| Date Mfgr Received | 2009-10-06 |
| Device Manufacturer Date | 2007-08-27 |
| Date Added to Maude | 2010-03-29 |
| 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 | LINDA BARLETTA |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242299 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MFG LTD |
| Manufacturer Street | CHAPEL LANE, SWORDS CO. |
| Manufacturer City | DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | IMMUNOASSAY SYSTEM |
| Product Code | KLT |
| Date Received | 2009-10-27 |
| Model Number | ADVIA CENTAUR XP |
| Catalog Number | 078-A010-XX |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-27 |