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 2016-03-16 for ADVIA CENTAUR XP TESTOSTERONE ASSAY N/A 10309989 manufactured by Siemens Healthcare Diagnostics, Inc..
[40528519]
The cause for the discordant advia centaur xp testosterone results during the lot to lot correlation study is unknown. Siemens healthcare diagnostics is investigating. The instrument is performing within specifications. The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. "
Patient Sequence No: 1, Text Type: N, H10
[40528520]
Discordant advia centaur xp testosterone results were obtained on samples from several patients during a lot to lot correlation study for reagent lots 181 and 200 with calibrator lot ce44. One sample showed a >30% difference between reagent lot 181 and lot 200. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant advia centaur xp testosterone result.
Patient Sequence No: 1, Text Type: D, B5
[42397078]
On 03/27/2016 additional information: siemens has reviewed best practices for performing a successful lot to lot correlation study with the customer. Siemens recommended using fresh materials and new calibrations for both lots. Ideally using the same calibrator lot. The samples should be run on both lots as close as possible to the same time. Testosterone samples must be only stored at room temp for 8 hours and 2-8c for 48 hours for stability. Due to the stability requirements it is recommended that the study be performed on same day. The sample selection can make an impact on the study. The samples used should have concentrations which cover the entire measurement range of the assay. The customer is satisfied with reagent lot 200 and will continue testing with the advia centaur xp testosterone assay. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2016-00055 |
| MDR Report Key | 5506142 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-03-16 |
| Date of Report | 2016-02-24 |
| Date of Event | 2016-02-24 |
| Date Mfgr Received | 2016-03-27 |
| Device Manufacturer Date | 2015-09-22 |
| Date Added to Maude | 2016-03-16 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. EIMAN SULIEMAN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604603 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP TESTOSTERONE ASSAY |
| Generic Name | TESTOSTERONE IMMUNOASSAY |
| Product Code | CDZ |
| Date Received | 2016-03-16 |
| Model Number | N/A |
| Catalog Number | 10309989 |
| Lot Number | 200 |
| Device Expiration Date | 2016-11-22 |
| 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 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-16 |