MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,litera report with the FDA on 2017-04-06 for ADVIA CENTAUR XP CORTISOL (COR) ASSAY N/A 10994926 manufactured by Siemens Healthcare Diagnostics, Inc..
[72333261]
Siemens is filing the mdr conservatively as a result of the data included in the article. Siemens is unaware of the lots used to generate the published data. The drug metyrapone is not currently listed in the specificity section of the advia centaur xp cortisol ifu. Siemens healthcare diagnostics is investigating. 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
[72333262]
In a recent peer-reviewed publication, the advia centaur xp cortisol assay was reported to show an elevated response in samples from patients receiving the drug metyrapone when compared to a candidate reference measurement procedure (crmp) based on lc/ms-ms. There was no report of adverse health consequences due to the discordant cortisol results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2017-00090 |
| MDR Report Key | 6464054 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2017-04-06 |
| Date of Report | 2017-04-06 |
| Date of Event | 2017-02-10 |
| Date Mfgr Received | 2017-03-12 |
| Date Added to Maude | 2017-04-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | E. 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 | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP CORTISOL (COR) ASSAY |
| Generic Name | CORTISOL IMMUNOASSAY |
| Product Code | JFT |
| Date Received | 2017-04-06 |
| Model Number | N/A |
| Catalog Number | 10994926 |
| 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 | 2017-04-06 |