MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-01-16 for ADVIA CENTAUR FOLATE (FOL) ASSAY N/A 06891541 manufactured by Siemens Healthcare Diagnostics, Inc..
[16550029]
A falsely elevated advia centaur folate result was obtained on a patient sample. The sample was diluted and the result was lower than expected. The sample was tested again diluted and the results were similar. The patient sample was sent to another site for testing with an alternate method. The result was in the normal range. 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
[16623111]
The cause for the discordant folate result is unknown. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2013-00004 |
| MDR Report Key | 2919120 |
| Report Source | 05,06 |
| Date Received | 2013-01-16 |
| Date of Report | 2012-12-21 |
| Date of Event | 2012-12-21 |
| Date Mfgr Received | 2012-12-21 |
| Date Added to Maude | 2013-04-08 |
| 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 FOLATE (FOL) ASSAY |
| Generic Name | FOLATE IMMUNOASSAY |
| Product Code | CGN |
| Date Received | 2013-01-16 |
| Model Number | N/A |
| Catalog Number | 06891541 |
| Lot Number | 214 |
| ID Number | N/A |
| Device Expiration Date | 2013-06-11 |
| 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 | 2013-01-16 |