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 2015-04-03 for ADVIA CENTAUR XP 078-A011-03 manufactured by Siemens Healthcare Diagnostics Inc..
[5679706]
Discordant, falsely elevated cardiac troponin i (tni-ultra) results were obtained on three patient samples on an advia centaur xp instrument. The discordant results were not reported to the physician(s). The samples were repeated on the same instrument, resulting lower. The corrected results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated tni-ultra results.
Patient Sequence No: 1, Text Type: D, B5
[13179166]
The cause of the discordant, falsely elevated tni-ultra results is unknown. Siemens is investigating this issue.
Patient Sequence No: 1, Text Type: N, H10
[32943782]
The initial mdr 2432235-2015-00159 was filed on april 03, 2015. Additional information (03/11/15): a siemens customer service engineer (cse) was dispatched to the customer site. After evaluation of the instrument and instrument data, the cse performed preventive maintenance service. The cse replaced the wash 1 solution lid due to a crack in the pick-up straw mounting bracket. The customer ran calibrations and quality controls. The cause of the discordant, falsely elevated tni-ultra results is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2015-00159 |
| MDR Report Key | 4659151 |
| Report Source | 01,05,06 |
| Date Received | 2015-04-03 |
| Date of Report | 2015-03-09 |
| Date of Event | 2015-03-06 |
| Date Mfgr Received | 2015-03-11 |
| Device Manufacturer Date | 2011-01-10 |
| Date Added to Maude | 2015-05-06 |
| 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 | MICHAEL METZ |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242223 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | MANUFACTURING LIMITED REGISTRATION NUMBER: 8020888 |
| Manufacturer City | CHAPEL LANE, SWORDS, CO., 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 | MOI |
| Date Received | 2015-04-03 |
| Model Number | ADVIA CENTAUR XP |
| Catalog Number | 078-A011-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2015-04-03 |