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 2017-04-12 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[72669726]
A siemens customer service engineer (cse) was dispatched to the customer's site. The cse reviewed the customer's calibration, quality control (qc) and sample repeat data. The customer's calibration and qc was in range at the time of the event. Siemens is investigating the event.
Patient Sequence No: 1, Text Type: N, H10
[72669727]
A discordant, falsely elevated carcinoembryonic antigen result was obtained on a patient sample on an advia centaur xp instrument. The initial result was reported out to the physician(s), which was questioned. The customer repeated the same sample an alternate advia centaur xp instrument, resulting lower. The customer repeated the same sample on the original advia centaur xp instrument, resulting lower than the initial result. A corrected report was issued to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated carcinoembryonic antigen result.
Patient Sequence No: 1, Text Type: D, B5
[77952022]
The initial mdr 2432235-2017-00245 was filed on april 12, 2017. Additional information (04/25/2017): the siemens headquarters support center (hsc) reviewed the event. The customer's calibration and quality control was in range at the time of the event. The issue was not able to be reproduced. No further issues were found. The cause of the discordant, falsely elevated carcinoembryonic antigen 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
| Report Number | 2432235-2017-00245 |
| MDR Report Key | 6488025 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-12 |
| Date of Report | 2017-05-25 |
| Date of Event | 2017-03-06 |
| Date Mfgr Received | 2017-04-25 |
| Device Manufacturer Date | 2009-02-02 |
| Date Added to Maude | 2017-04-12 |
| 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 | TIMOTHY RICE |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242406 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD |
| Manufacturer Street | REGISTRATION NUMBER: 8020888 CHAPEL LANE |
| 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 | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DHX |
| Date Received | 2017-04-12 |
| Model Number | ADVIA CENTAUR XP |
| 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 XP |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-04-12 |
| 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 | 2017-04-12 |