MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-01-09 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[96826232]
The customer contacted siemens customer care center (ccc) to report the discordant alpha-fetoprotein (afp) result. A siemens customer service engineer (cse) was dispatched to the customer site. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[96826233]
A discordant, falsely elevated alpha-fetoprotein (afp) result was obtained on one patient sample for one of the replicates on an advia centaur xp instrument. The sample was run in replicates of three. The first and third replicates had resulted lower, while the second replicate result was falsely elevated. Only the lower result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated afp result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2018-00021 |
| MDR Report Key | 7176318 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-09 |
| Date of Report | 2018-05-03 |
| Date of Event | 2017-12-13 |
| Date Mfgr Received | 2018-04-17 |
| Device Manufacturer Date | 2011-01-17 |
| Date Added to Maude | 2018-01-09 |
| 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 | ROLANDO HUALPA |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242963 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD |
| Manufacturer Street | CHAPEL LANE REGISTRATION NUMBER: 8020888 |
| Manufacturer City | 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 | ADVIA CENTAUR XP |
| Product Code | LOJ |
| Date Received | 2018-01-09 |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | ADVIA CENTAUR XP |
| Product Code | JJE |
| Date Received | 2018-01-09 |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-09 |