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 2017-02-06 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[66668182]
The customer contacted the siemens customer care center (ccc). The customer stated that they had observed erratic patient and quality control (qc) results and the cea assay was failing calibration. A siemens customer service engineer (cse) was dispatched to the customer site. After evaluating the instrument, the cse performed a total service visit and found aspirate probe 1 was not aspirating. The cse replaced the aspirate probe and tested it. The cse cleaned the bottom of the main manifold and ran and empty and fill of cuvettes. The cse ran quality control (qc), resulting satisfactory. The cause of the discordant, falsely elevated cea results 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
[66668183]
Discordant, falsely elevated carcinoembryonic antigen (cea) results were obtained on patient samples on an advia centaur xp instrument. The discordant results were reported to the physician(s) who questioned them, as the results did not align with previous results from the patients. The patient samples were repeated and results were similar to the previous results from the patients. There are no known reports of patient intervention or adverse health consequences due to discordant, falsely elevated cea results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00099 |
| MDR Report Key | 6305599 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-06 |
| Date of Report | 2017-02-06 |
| Date of Event | 2017-01-10 |
| Date Mfgr Received | 2017-01-12 |
| Device Manufacturer Date | 2015-08-24 |
| Date Added to Maude | 2017-02-06 |
| 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 | MS. CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | MANUFACTURING LIMITED REGISTRATION NUMBER: 8020888 |
| Manufacturer City | CHAPEL LANE, DUBLIN, SWORDS, |
| 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 | DHX |
| Date Received | 2017-02-06 |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-02-06 |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-06 |