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 2016-03-11 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[40166583]
The customer contacted a siemens customer care center (ccc) specialist. A siemens customer service engineer (cse) specialist recommended that the customer change the software setting for the instrument so that the instrument will holds the sample's initial result when dilution is needed. Upon cse's instructions, the customer determined that the auto dilution was not configured properly and corrected the setting. The cause of the discordant, falsely low progesterone result on one patient sample was related to an incorrect software setting. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[40166584]
A discordant, falsely low progesterone 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 sample was diluted with a dilution factor of 1:5 and repeated on the same instrument, resulting higher than the initial result. The corrected result was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low progesterone result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2016-00122 |
| MDR Report Key | 5494949 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-03-11 |
| Date of Report | 2016-02-16 |
| Date of Event | 2016-02-16 |
| Date Mfgr Received | 2016-02-16 |
| Device Manufacturer Date | 2015-07-06 |
| Date Added to Maude | 2016-03-11 |
| 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 | 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 |
| 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 XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | JLS |
| Date Received | 2016-03-11 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-11 |