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 2013-11-20 for ADVIA CENTAUR 078-A001-13 manufactured by Siemens Healthcare Diagnostics Inc..
[4018578]
A discordant, false non-reactive (b)(6) result was obtained on one patient sample on an advia centaur instrument. The discordant result was not reported to the physician(s). The sample was rerun on the same instrument and resulted as reactive. The rerun result was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, (b)(6) result.
Patient Sequence No: 1, Text Type: D, B5
[11256166]
The customer contacted the siemens technical solutions center (tsc). During troubleshooting, the customer informed the tsc specialist that the sample had been run without a barcode when it resulted non-reactive. There is no traceability to the sample because it was run without a barcode, and therefore it is unknown if the correct sample was tested during the initial run. The patient sample resulted as expected when tested on the same instrument. There were no known issues with any other ahcv results or any other assay results. The cause of the discordant, false non-reactive ahcv result is unknown. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2013-00559 |
| MDR Report Key | 3479641 |
| Report Source | 01,05,06 |
| Date Received | 2013-11-20 |
| Date of Report | 2013-10-30 |
| Date of Event | 2013-10-29 |
| Date Mfgr Received | 2013-10-30 |
| Device Manufacturer Date | 2006-06-19 |
| Date Added to Maude | 2014-02-27 |
| 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 AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD. |
| Manufacturer Street | CHAPEL LANE REGISTRATION NUMBER: 8020888 |
| Manufacturer City | DUBLIN, SWORDS, CO. |
| 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 | MZP |
| Date Received | 2013-11-20 |
| Model Number | ADVIA CENTAUR |
| Catalog Number | 078-A001-13 |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-20 |