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 2017-11-27 for ADVIA CENTAUR XPT manufactured by Siemens Healthcare Diagnostics Inc..
[93576776]
A siemens customer service engineer (cse) was at the customer site. The cse ran dry test, wet water test and wet wash1 test in replicates of thirty and used laboratory water as sample to run afp and cardiac troponin i. The cse determined that there were solution stain marks underneath the wash manifold near acid probe. Additionally, the cse found that during the daily cleaning procedure the aspirate probe 3 was overflowing. There was no overflow during the sample processing. A siemens headquarters support center (hsc) specialist stated that the residual film around the wash 1 dispense port could be the result of wicking from droplets accumulating on the port. The hsc specialist also stated that as the first result was discordant and subsequent results were correct, it may indicate that there is loss of prime of the wash fluid at dispense port 1 or 3. The cause of the imprecise afp results on one patient sample is unknown. Siemens is investigating the issue. Mdr 2432235-2017-00531 was filed for the event occurred on (b)(6) 2017. Mdr 2432235-2017-00599 was filed for the event occurred on (b)(6) 2017.
Patient Sequence No: 1, Text Type: N, H10
[93576777]
Imprecise alpha-fetoprotein (afp) results were obtained on one patient sample on an advia centaur xpt instrument. The sample was repeated twice, resulting lower. It is unknown if the sample was repeated on the same instrument or alternate instrument. It is unknown if the initial or repeat result was reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the imprecise afp result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00625 |
| MDR Report Key | 7060697 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-27 |
| Date of Report | 2018-07-23 |
| Date of Event | 2017-11-02 |
| Date Mfgr Received | 2018-05-07 |
| Device Manufacturer Date | 2016-11-07 |
| Date Added to Maude | 2017-11-27 |
| 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 | 2017-11-27 |
| 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 | 2017-11-27 |
| 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 | 2017-11-27 |