MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-03-16 for ADVIA CENTAUR XP CORTISOL (COR) ASSAY N/A 04610138 manufactured by Siemens Healthcare Diagnostics, Inc..
[2541347]
The customer has observed accumulation of solid phase particles lines on the sides of the advia centaur xp cortisol reagent ready packs and failed quality control results within onboard stability. The siemens technical application specialist (tas) mixed the reagent pack and the quality control was within range. There was no report of adverse health consequences due to the failed onboard cortisol quality control results.
Patient Sequence No: 1, Text Type: D, B5
[9697608]
Siemens has investigated and confirmed the customer's observation of reagent pack solid phase banding (lines) that affects the onboard stability of the reagents which has the potential to affect both controls and patient results over the onboard stability period. An urgent field safety notice ((b)(4)) was distributed to customers in (b)(6) 2012 to address this issue.
Patient Sequence No: 1, Text Type: N, H10
[10436971]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2012-00132 |
| MDR Report Key | 2494502 |
| Report Source | 05,06 |
| Date Received | 2012-03-16 |
| Date of Report | 2011-12-19 |
| Date of Event | 2011-12-15 |
| Date Mfgr Received | 2013-02-06 |
| Date Added to Maude | 2012-03-27 |
| 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 | 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 | IN |
| 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 | 2012-03-16 |
| Model Number | N/A |
| Catalog Number | 04610138 |
| Lot Number | 254 |
| Device Expiration Date | 2012-05-23 |
| 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 | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-16 |