MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-22 for ADVIA CENTAUR XP CORTISOL (COR) ASSAY N/A 04610138 manufactured by Siemens Healthcare Diagnostics, Inc..
[2712823]
The customer reported that they did not receive an advia centaur xp cortisol urgent field safety notice ((b)(4)) that was distributed to customers in march 2012. There was no report of adverse health consequences.
Patient Sequence No: 1, Text Type: D, B5
[9932003]
Urgent field safety notice ((b)(4)) was provided to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2012-00217 |
| MDR Report Key | 2584167 |
| Report Source | 05,06 |
| Date Received | 2012-05-22 |
| Date of Report | 2012-04-23 |
| Date of Event | 2012-03-07 |
| Date Mfgr Received | 2012-04-23 |
| Date Added to Maude | 2012-09-25 |
| 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 | MR. STEPHEN PERRY |
| Manufacturer Street | 333 CONEY ST. |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604163 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1390-2012 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP CORTISOL (COR) ASSAY |
| Generic Name | CORTISOL IMMUNOASSAY |
| Product Code | JFT |
| Date Received | 2012-05-22 |
| Model Number | N/A |
| Catalog Number | 04610138 |
| Lot Number | 256 |
| 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 | 2012-05-22 |