MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-10-24 for ADVIA CENTAUR CP CORTISOL (COR) ASSAY N/A 04610138 manufactured by Siemens Healthcare Diagnostics, Inc..
[21728332]
A false low advia centaur cp cortisol result was obtained for a patient sample. The result was obtained after dexamethason administration. Repeat testing was performed on the patient sample and the results were high. It is unknown if patient treatment was prescribed or altered. There was no report of adverse health consequences due to the discordant cortisol results.
Patient Sequence No: 1, Text Type: D, B5
[21885943]
The cause for the discordant cortisol result is unknown. The quality control and the calibration were acceptable. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2013-00252 |
| MDR Report Key | 3427065 |
| Report Source | 05,06 |
| Date Received | 2013-10-24 |
| Date of Report | 2013-09-30 |
| Date of Event | 2013-09-13 |
| Date Mfgr Received | 2013-09-13 |
| Date Added to Maude | 2014-01-27 |
| 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 | 0 |
| Event Location | 0 |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR CP CORTISOL (COR) ASSAY |
| Generic Name | CORTISOL IMMUNOASSAY |
| Product Code | JFT |
| Date Received | 2013-10-24 |
| Model Number | N/A |
| Catalog Number | 04610138 |
| Lot Number | 261 |
| ID Number | N/A |
| Device Expiration Date | 2014-05-21 |
| 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 | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-24 |