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 2018-04-16 for ADVIA CENTAUR XPT manufactured by Siemens Healthcare Diagnostics Inc..
[106025276]
Siemens technical support laboratory performed in-house testing with afp kit lots 04191 and 041199. Calibrations and quality controls were within acceptable ranges. The kit lots are performing within manufacturing specifications. Siemens is investigating the issue. Mdrs 2432235-2017-00531_s4 , mdr 2432235-2017-00599_s2, mdr 2432235-2017-00625_s2, and mdr 2432235-2017-00660_s1 were filed for the same issue.
Patient Sequence No: 1, Text Type: N, H10
[106025277]
A discordant, falsely elevated alpha-fetoprotein (afp) result was obtained on one patient sample on an advia centaur xpt instrument. The sample was repeated twice on the same instrument, resulting lower. It is unknown if the initial or repeat results were reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated afp result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2018-00156 |
| MDR Report Key | 7433696 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-16 |
| Date of Report | 2018-07-23 |
| Date of Event | 2018-03-22 |
| Date Mfgr Received | 2018-05-07 |
| Device Manufacturer Date | 2016-11-07 |
| Date Added to Maude | 2018-04-16 |
| 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 | SHWETA GULATI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242870 |
| 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 XPT |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | LOJ |
| Date Received | 2018-04-16 |
| Model Number | ADVIA CENTAUR XPT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 XPT |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | JJE |
| Date Received | 2018-04-16 |
| Model Number | ADVIA CENTAUR XPT |
| 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 | 2018-04-16 |