MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-08 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics, Inc..
[25887005]
A siemens customer service engineer (cse) was dispatched to the customer site. The cse replaced aspiration probes and the wash separation manifold. A siemens headquarters support center (hsc) specialist evaluated the instrument data and determined it is unlikely that those parts caused the discordant havt results. The cause of the discordant results is unknown. This instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[25887006]
Discordant, false positive total antibodies to hepatitis a virus (havt) results were obtained on multiple patient samples on an advia centaur xp instrument. The discordant results were not reported to the physician(s). The samples were repeated on the same instrument and resulted negative. It is unknown if the repeat results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant havt results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2015-00395 |
| MDR Report Key | 5060874 |
| Date Received | 2015-09-08 |
| Date of Report | 2015-08-19 |
| Date of Event | 2015-08-18 |
| Date Mfgr Received | 2015-08-19 |
| Device Manufacturer Date | 2007-09-10 |
| Date Added to Maude | 2015-09-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | LOB |
| Date Received | 2015-09-08 |
| Model Number | ADVIA CENTAUR XP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| 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 | 2015-09-08 |