MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-07-20 for ADVIA CENTAUR XP FOLATE (FOL) ASSAY N/A 06891541 manufactured by Siemens Healthcare Diagnostics, Inc..
[2817878]
Low bias advia centaur folate results were observed by the customer with controls and patients when switching to reagent lot# 211 from lot# 210. It is unknown if patient treatment was 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
[9986597]
The cause for the discordant folate results is unknown. Siemens healthcare diagnostics is investigating the cause of the discordant results.
Patient Sequence No: 1, Text Type: N, H10
[10261639]
Siemens filed the initial mdr on (b)(4) 2012. (b)(6) 2012: additional information: siemens performed an investigation and internal testing was performed evaluating folate reagent lot#s 210, 211 and 212. The internal data did not confirm the quality control bias or the patient bias that was observed by the customer. Recommendations were made to ensure that the instrument reagent probe wash bowls were cleaned weekly, reagent packs are mixed for an extra 30 seconds after the solid phase is resuspended and that the temperature of the laboratory is monitored. The customer continues to use folate reagent lot# 211 at this time with acceptable performance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2012-00281 |
| MDR Report Key | 2663045 |
| Report Source | 05,06 |
| Date Received | 2012-07-20 |
| Date of Report | 2012-06-22 |
| Date of Event | 2012-06-21 |
| Date Mfgr Received | 2012-11-27 |
| Device Manufacturer Date | 2012-03-22 |
| Date Added to Maude | 2012-11-13 |
| 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 | 2012-07-20 |
| 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 | 2012-07-20 |