MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-06-05 for ADVIA CENTAUR CP CORTISOL IMMUNOASSAY N/A 04610049 manufactured by Siemens Healthcare Diagnostics, Inc..
[3532106]
The customer reported that they did not receive an advia centaur cp cortisol urgent field safety notice (b)(4) that was distributed to customers in march 2012. The customer had received a new reagent lot of cortisol with a note card that referred to the urgent field safety notice and affected reagent lots. There was no report of adverse health consequences.
Patient Sequence No: 1, Text Type: D, B5
[10832236]
Urgent field safety notice (b)(4) was provided to the customer. The customer has configured the calibration interval to every 24 hours for daily calibration.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2013-00129 |
| MDR Report Key | 3147253 |
| Report Source | 05,06 |
| Date Received | 2013-06-05 |
| Date of Report | 2013-05-15 |
| Date of Event | 2012-11-01 |
| Date Mfgr Received | 2013-05-15 |
| Date Added to Maude | 2013-08-26 |
| 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 | 0 |
| Event Location | 0 |
| 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 City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 10591 |
| 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 CP CORTISOL IMMUNOASSAY |
| Generic Name | CORTISOL ASSAY |
| Product Code | JFT |
| Date Received | 2013-06-05 |
| Model Number | N/A |
| Catalog Number | 04610049 |
| Lot Number | 254-257 |
| ID Number | N/A |
| 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 | 2013-06-05 |