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..
[72392259]
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. Siemens healthcare diagnostics is investigating.
Patient Sequence No: 1, Text Type: N, H10
[72392260]
In a recent peer-reviewed publication, the advia centaur xp cortisol assay was reported to show significant under-recovery rates in samples of pregnant females relative to non-pregnant females 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
[81020202]
Siemens filed the initial mdr 1219913-2017-00089 on april 6, 2017. On 05/12/2017 additional information: the initial mdr was filed conservatively. The bland-altman bias plot for the pregnant cohort in the article had target values from 100 to 1100 nmol/l. Upon further review of the bland-altman bias plot for the pregnant cohort, the values of 600 nmol/l and lower had a percent difference of approximately -18%. This is less than the -25% criteria for clinical impact. The values greater than 600 were all above the reference interval and did not have a potential for clinical impact. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2017-00089 |
| MDR Report Key | 6464044 |
| 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 |