MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2015-11-04 for ADVIA CENTAUR XP FOLATE (FOL) ASSAY N/A 06891541 manufactured by Siemens Healthcare Diagnostics, Inc..
[30344128]
The cause for the falsely elevated advia centaur xp folate (fol) results observed by the customer compared to an alternate test method is unknown. Siemens has inquired if the patient sample is available for further investigation.
Patient Sequence No: 1, Text Type: N, H10
[30344129]
A falsely elevated advia centaur xp folate (fol) result was observed by the customer on a patient sample and considered discordant compared to an alternate test method result. The patient sample was manually diluted and retested on the advia centaur xp and the result was low. The customer performed repeat testing on another advia centaur xp reagent lot, and the result was high compared to the alternate test method result. The patient sample was auto diluted and the result was low. There are no known reports of patient treatment being altered or prescribed or adverse health consequences due to the elevated advia centaur xp folate result.
Patient Sequence No: 1, Text Type: D, B5
[32690279]
Siemens filed the initial mdr 1219913-2015-00171 on (b)(6) 2015 for a falsely elevated advia centaur xp folate (fol) result on a patient sample. On (b)(6) 2015 additional information: the cause for the falsely elevated advia centaur xp folate (fol) patient result when compared to an alternate test method result unknown. The patient sample is not available for further investigation by siemens. No conclusion can be drawn. The instrument is performing within specifications. No further investigation is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2015-00171 |
| MDR Report Key | 5200421 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-11-04 |
| Date of Report | 2015-10-13 |
| Date of Event | 2015-10-05 |
| Date Mfgr Received | 2015-12-04 |
| Device Manufacturer Date | 2015-06-16 |
| Date Added to Maude | 2015-11-04 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. STEPHEN PERRY |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604163 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| 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: |
| Product Code | CGN |
| Date Received | 2015-11-04 |
| Model Number | N/A |
| Catalog Number | 06891541 |
| Lot Number | 071236 |
| Device Expiration Date | 2016-03-16 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2015-11-04 |