MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-03-18 for ADVIA CENTAUR CP 086-A002-01 manufactured by Siemens Healthcare Diagnostics Inc..
[21313770]
A discordant, falsely elevated free thyroxine (ft4) result was obtained on one patient sample on an advia centaur cp instrument. The discordant result was reported to the physician(s), who questioned it. The sample was tested from pour off tubes on the same instrument and an alternate instrument, both resulting lower. It is unknown if the rerun results from the alternate instrument were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated ft4 result.
Patient Sequence No: 1, Text Type: D, B5
[21662381]
A siemens customer service engineer (cse) was dispatched to the customer site. After evaluation of the instrument and instrument data, the cse replaced the long and short sample tubing as well as the z axis motor and adjusted the pressure. Quality controls were run, resulting within range. The cause of the discordant, falsely elevated ft4 result is unknown, as the sample resulted as expected upon repeat testing on the same instrument. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[33620685]
The initial mdr 2432235-2014-00236 was filed on march 17, 2014. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2014-00236 |
| MDR Report Key | 3684017 |
| Report Source | 05,06 |
| Date Received | 2014-03-18 |
| Date of Report | 2014-02-19 |
| Date of Event | 2014-02-18 |
| Date Mfgr Received | 2014-03-19 |
| Date Added to Maude | 2014-05-19 |
| 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 AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | STRATEC BIOMEDICAL SWITZERLAND AG |
| Manufacturer Street | REGISTRATION #: 3008494306 GEWERBESTRASSE 6 |
| Manufacturer City | NEUHAUSEN AM RHEINFALL, 8212 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR CP |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | KLI |
| Date Received | 2014-03-18 |
| Model Number | ADVIA CENTAUR CP |
| Catalog Number | 086-A002-01 |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2014-03-18 |