MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-07-19 for ADVIA CENTAUR XP FOLATE (FOL) ASSAY N/A 06891541 manufactured by Siemens Healthcare Diagnostics, Inc..
[10154802]
(b)(4). A siemens field service engineer (fse) was sent to the customer site. The fse repaired tubing connections at the base dispense probe, replaced luminometer cover, and replaced probes. The quality control for the folate assay was run and was acceptable. Siemens performed an investigation and the internal data did not confirm the quality control bias or the patient bias that was observed by the customer for the folate assay prior to service.
Patient Sequence No: 1, Text Type: N, H10
[18414383]
Low bias advia centaur xp folate results were observed by the customer with controls and patients when switching to reagent lot# 211. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant folate results.
Patient Sequence No: 1, Text Type: D, B5
[18679511]
The cause for the discordant folate results is unknown. A siemen's representative was sent to the customer site. The siemen's representative performed testing using fresh reagents and the results were the same. Siemens healthcare diagnostics is investigating the cause of the discordant results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2012-00277 |
| MDR Report Key | 2662272 |
| Report Source | 05,06 |
| Date Received | 2012-07-19 |
| Date of Report | 2012-06-20 |
| Date of Event | 2012-06-20 |
| Date Mfgr Received | 2012-08-23 |
| Device Manufacturer Date | 2012-03-22 |
| Date Added to Maude | 2012-11-09 |
| 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 FOLATE (FOL) ASSAY |
| Generic Name | FOLATE IMMUNOASSAY |
| Product Code | CGN |
| Date Received | 2012-07-19 |
| Model Number | N/A |
| Catalog Number | 06891541 |
| Lot Number | 211 |
| ID Number | N/A |
| Device Expiration Date | 2012-12-22 |
| 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 | 2012-07-19 |