MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-07-28 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[81304854]
The customer contacted the siemens customer care center (ccc) to report the discordant carcinoembryonic antigen (cea) result. A siemens customer service engineer (cse) was dispatched to the customer site. The cse found the window for the ring loader missing and in the bottom of the instrument. The cse replaced aspirate 4 probe. The cse made adjustments to the sample, reagent and aspirate probes. The cse checked wash dispense volumes. The cse ran sample with 80 results, and all were good. The cse ran quality control (qc), and results were acceptable. The cause of the discordant cea result is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[81304855]
A discordant, falsely low carcinoembryonic antigen (cea) result was obtained on one patient sample on an advia centaur xp instrument. The discordant result was reported to the physician(s), who questioned it. The same sample was repeated on an alternate instrument, resulting higher. The corrected result was reported to physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant cea result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00442 |
| MDR Report Key | 6751204 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-28 |
| Date of Report | 2017-07-28 |
| Date of Event | 2017-07-05 |
| Date Mfgr Received | 2017-07-06 |
| Device Manufacturer Date | 2008-07-21 |
| Date Added to Maude | 2017-07-28 |
| 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 | 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 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 | DHX |
| Date Received | 2017-07-28 |
| 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 | 2017-07-28 |
| Model Number | ADVIA CENTAUR XP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-07-28 |