MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-20 for ADVIA CENTAUR CP FOLATE (FOL) ASSAY N/A 06891541 manufactured by Siemens Healthcare Diagnostics, Inc..
[2804615]
Low bias advia centaur cp folate results were observed by the customer with controls and patients when switching to reagent lot# 211 from lot# 210. The patient results were outside of the customer's acceptable limit of 10%. 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
[10125359]
The customer has opted not to use folate reagent lot# 211 as the lot to lot correlation failed. The customer has received folate reagent lot # 212 and performed lot to lot correlation with reagent lot # 210. The lot to lot correlation did not show a bias. The customer is reporting patient results using reagent lot# 212 for folate. The cause for the discordant folate results is unknown with lot# 211. Siemens healthcare diagnostics is investigating the cause of the discordant results.
Patient Sequence No: 1, Text Type: N, H10
[10301563]
Siemens filed the initial mdr on (b)(4) 2012. (b)(6) 2012: additional information: siemens performed an investigation for reagent lot# 211 and the internal quality control release data did not show an issue. Based on results of investigation, no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2012-00305 |
| MDR Report Key | 2706643 |
| Report Source | 05,06 |
| Date Received | 2012-08-20 |
| Date of Report | 2012-06-27 |
| Date of Event | 2012-06-27 |
| Date Mfgr Received | 2012-08-02 |
| Device Manufacturer Date | 2012-03-22 |
| Date Added to Maude | 2012-12-06 |
| 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 CP FOLATE (FOL) ASSAY |
| Generic Name | FOLATE IMMUNOASSAY |
| Product Code | CGN |
| Date Received | 2012-08-20 |
| 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 | 2012-08-20 |