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 2014-07-22 for ADVIA CENTAUR 078-A001 manufactured by Siemens Healthcare Diagnostics Inc..
[16309568]
A discordant, (b)(6) antibody to (b)(6) result was obtained on one patient sample on a advia centaur instrument. The discordant result was reported to the physician(s), who questioned it. The sample was repeated twice on an alternate system, 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) result.
Patient Sequence No: 1, Text Type: D, B5
[16441762]
A siemens customer service engineer (cse) was dispatched to the customer site. The cse evaluated the instrument and instrument data and adjusted the sample probe inside the reaction cuvette. The cause of the discordant (b)(6) result is unknown. The cse performed an instrument check and successfully ran quality controls. The instrument is performing to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2014-00478 |
| MDR Report Key | 3951413 |
| Report Source | 01,05,06 |
| Date Received | 2014-07-22 |
| Date of Report | 2014-06-27 |
| Date of Event | 2014-06-25 |
| Date Mfgr Received | 2014-06-27 |
| Device Manufacturer Date | 2009-01-16 |
| Date Added to Maude | 2014-07-24 |
| 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 |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | OBF |
| Date Received | 2014-07-22 |
| Model Number | ADVIA CENTAUR |
| Catalog Number | 078-A001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 YR |
| 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 | 2014-07-22 |