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 2015-03-02 for ADVIA CENTAUR XP 078-A010 manufactured by Siemens Healthcare Diagnostics Inc..
[5471147]
Discordant, (b)(6) results were obtained on four patient samples on a advia centaur xp instrument. The initial (b)(6) results were reported to the physician(s), who questioned them. Three samples were repeated two times on the same system, resulting (b)(6). One patient was repeated once, which resulted (b)(6). The corrected (b)(6) results were 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
[12936960]
A siemens customer service engineer (cse) was dispatched to the customer site. The cse evaluated the instrument and instrument data. The cse replaced the incubation ring belt and checked the sample probe, (b)(6) probe and wash probe alignments. The cse also performed an acid and base volume check. The cause of the discordant (b)(6) results is unknown. The cse successfully ran quality controls and samples. The instrument is performing to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2015-00102 |
| MDR Report Key | 4561333 |
| Report Source | 01,05,06 |
| Date Received | 2015-03-02 |
| Date of Report | 2015-02-09 |
| Date of Event | 2015-01-30 |
| Date Mfgr Received | 2015-02-09 |
| Device Manufacturer Date | 2007-05-17 |
| Date Added to Maude | 2015-04-02 |
| 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 | JOHN NELSON |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | REGISTRATION NUMBER: 8020888 CHAPEL LANE, SWORDS |
| Manufacturer City | 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 | OBF |
| Date Received | 2015-03-02 |
| Model Number | ADVIA CENTAUR XP |
| Catalog Number | 078-A010 |
| 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 | 2015-03-02 |