MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-10-29 for ADVIA CENTAUR 078-A001-08 manufactured by Siemens Healthcare Diagnostics, Inc..
[5043333]
(b)(6) results were obtained on multiple patient samples on an advia centaur instrument. The initial results were not reported to the physician(s). The samples were repeated on the same system. It is unknown as to which repeat (b)(6) results were reported to the physician(s). There are no known reports of adverse health consequences or patient intervention due to the discordant (b)(6) results.
Patient Sequence No: 1, Text Type: D, B5
[12448139]
A siemens customer service engineer (cse) was dispatched to the customer site. After evaluation of the instrument and instrument data, the cse replaced the dispense diluter 1 assembly. The cse also performed an instrument service check. The cause of the discordant (b)(6) results is unknown. The cse successfully ran a dispense test and quality controls. The instrument is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2014-00625 |
| MDR Report Key | 4212192 |
| Report Source | 05,06 |
| Date Received | 2014-10-29 |
| Date of Report | 2014-10-04 |
| Date of Event | 2014-10-04 |
| Date Mfgr Received | 2014-10-04 |
| Device Manufacturer Date | 2005-09-29 |
| Date Added to Maude | 2014-11-12 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| 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 | 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 |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | NHS |
| Date Received | 2014-10-29 |
| Model Number | ADVIA CENTAUR |
| Catalog Number | 078-A001-08 |
| ID Number | N/A |
| 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 | 2014-10-29 |