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 2015-05-27 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[5927970]
Discordant results were obtained on patient samples tested for multiple methods on an advia centaur xp instrument. The acid and base solutions ran out and the results were flagged by the instrument with signal errors. Discordant results were erroneously reported to the physician(s). Repeat testing was performed on an alternate advia centaur instrument. It is unknown if corrected reports were sent out. There are no reports of patient intervention or adverse health consequences due to the discordant results.
Patient Sequence No: 1, Text Type: D, B5
[13416973]
The customer contacted the siemens customer care center (ccc). The customer stated that the acid and base solutions ran out on the instrument. The operator did not realize this and proceeded to run samples on the instrument. The cause of the discordant results was due to a user error. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[32590564]
The initial mdr 2432235-2015-00257 was filed on may 27, 2015. Additional information (06/26/2015): the customer provided an attachment with patient data. It is unknown which of the results provided are corrected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2015-00257 |
| MDR Report Key | 4799024 |
| Report Source | 01,05,06 |
| Date Received | 2015-05-27 |
| Date of Report | 2015-05-06 |
| Date of Event | 2015-05-06 |
| Date Mfgr Received | 2015-06-26 |
| Device Manufacturer Date | 2008-02-18 |
| Date Added to Maude | 2015-06-24 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| 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 XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | MOI |
| Date Received | 2015-05-27 |
| Model Number | ADVIA CENTAUR XP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2015-05-27 |