MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-12-08 for ADVIA CENTAUR XP FT4 N/A 08074354 manufactured by Siemens Healthcare Diagnostics, Inc..
[2462432]
A false low advia centaur xp ft4 result was obtained for a patient sample. The result was questioned. Repeat testing was performed on the other advia centaur xp and an alternate method. The results were higher. There was no report of adverse health consequences due to the discordant ft4 result.
Patient Sequence No: 1, Text Type: D, B5
[9496031]
A siemens field service engineer (fse ) was sent to the customer site for system inspection. The fse performed preventative maintenance and adjusted reagent probe 1. The fse performed a precision run using previous discrepant patient sample. The values for the patient sample were similar to the results obtained on the other advia centaur xp and the alternate method. No conclusion can be drawn. The instrument is performing within specification. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2011-00182 |
| MDR Report Key | 2363478 |
| Report Source | 05,06 |
| Date Received | 2011-12-08 |
| Date of Report | 2011-11-09 |
| Date of Event | 2011-11-07 |
| Date Mfgr Received | 2011-11-09 |
| Date Added to Maude | 2012-05-25 |
| 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 | 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 | 2011-12-08 |
| Model Number | N/A |
| Catalog Number | 08074354 |
| Lot Number | 032 |
| ID Number | N/A |
| Device Expiration Date | 2012-08-18 |
| 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 | 2011-12-08 |