MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-30 for ADVIA CENTAUR XP FT4 N/A 08074354 manufactured by Siemens Healthcare Diagnostics, Inc..
[21760500]
Elevated advia centaur xp ft4 results were obtained for samples from one patient. The results were discordant with an alternate method. There was no report of adverse health consequences due to the discordant ft4 result.
Patient Sequence No: 1, Text Type: D, B5
[21898407]
The cause for the discordant ft4 results is unknown. The quality control and calibration were within acceptable range. The instrument is performing within specification. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2011-00179 |
| MDR Report Key | 2352498 |
| Report Source | 05,06 |
| Date Received | 2011-11-30 |
| Date of Report | 2011-11-01 |
| Date of Event | 2011-09-14 |
| Date Mfgr Received | 2011-11-01 |
| Date Added to Maude | 2011-12-01 |
| 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 XP FT4 |
| Generic Name | FT4 |
| Product Code | CDX |
| Date Received | 2011-11-30 |
| Model Number | N/A |
| Catalog Number | 08074354 |
| Lot Number | 028 |
| ID Number | N/A |
| Device Expiration Date | 2012-03-23 |
| 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 | 2011-11-30 |