MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-17 for ADVIA CENTAUR XP 078-A011-03 manufactured by Siemens Healthcare Diagnostics Inc..
[21266360]
Discordant, (b)(6) results were obtained on one patient sample on an advia centaur xp instrument upon a duplicate repeat run. The discordant results were not reported to the physician(s). The sample resulted (b)(6) upon initial run, which matched the patient? S clinical history. The sample was repeated in duplicate on the same instrument and results were (b)(6). The sample was repeated again on an alternate instrument, resulting (b)(6). The corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, (b)(6) results.
Patient Sequence No: 1, Text Type: D, B5
[21274346]
A siemens customer service engineer (cse) was at the customer site. After evaluation of the instrument and instrument data, the cse did not find an instrument malfunction. The cse proactively ordered the customer new calibration materials and acid and base reagents. The cause of discordant, (b)(6) 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 | 2432235-2013-00609 |
| MDR Report Key | 3524311 |
| Report Source | 05,06 |
| Date Received | 2013-12-17 |
| Date of Report | 2013-11-22 |
| Date of Event | 2013-11-08 |
| Date Mfgr Received | 2013-11-22 |
| Device Manufacturer Date | 2009-10-12 |
| Date Added to Maude | 2014-03-28 |
| 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 AVENUE |
| Manufacturer City | TARRYTOWN 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | REGISTRATION NUMBER: 8020888 MANUFACTURING LIMITED |
| Manufacturer City | CHAPEL LANE, DUBLIN, SWORDS, CO. |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | MZP |
| Date Received | 2013-12-17 |
| Model Number | ADVIA CENTAUR XP |
| Catalog Number | 078-A011-03 |
| 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 | 2013-12-17 |