MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-11-25 for ADVIA CENTAUR XP 078-A010-02 manufactured by Siemens Healthcare Diagnostics Inc..
[5005698]
A discordant, falsely low testosterone result was obtained on one patient sample on an advia centaur xp instrument. The discordant result was not reported to the physician(s). The sample was repeated once from the original tube and once from an aliquot on the same instrument, resulting higher. The corrected result from the aliquot was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low testosterone result.
Patient Sequence No: 1, Text Type: D, B5
[12523546]
A siemens customer service engineer (cse) was dispatched to the customer site. Prior to cse arrival, the customer reran a few patient samples processed before and after the sample in question, and all resulted as expected. After evaluation of the instrument and instrument data, the cse discovered the base pump leaking at the connector, and replaced the pump. Quality controls were run, resulting within range. The cause of the discordant, falsely low testosterone 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 | 2432235-2014-00699 |
| MDR Report Key | 4278110 |
| Report Source | 05,06 |
| Date Received | 2014-11-25 |
| Date of Report | 2014-10-29 |
| Date of Event | 2014-10-28 |
| Date Mfgr Received | 2014-10-29 |
| Device Manufacturer Date | 2011-06-27 |
| Date Added to Maude | 2014-12-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN 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 | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CDZ |
| Date Received | 2014-11-25 |
| Model Number | ADVIA CENTAUR XP |
| Catalog Number | 078-A010-02 |
| 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 | 2014-11-25 |