MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-11-27 for ADVIA CENTAUR XP FOLATE (FOL) ASSAY N/A 06891541 manufactured by Siemens Healthcare Diagnostics, Inc..
[4039111]
Falsely low advia centaur xp folate results were observed by the customer on two of the patient results and were considered discordant when compared to higher results when repeated on their alternate advia centaur system. The customer performed a quality control run later in the day that failed and the patient samples that were run previously were repeated. All of the other patient samples that were repeated agreed with the initial results. Corrected results were provided by the customer for the two discordant patient results. There was no known report of patient treatment being altered or adverse health consequences due to the lower advia centaur xp folate results.
Patient Sequence No: 1, Text Type: D, B5
[11348706]
A siemens field service engineer (fse) was sent to the customer site for system inspection. The fse observed that the silicon tubing for the aspirate probe 2 was not properly seated inside the pinch valve. The fse re-seated the silicon tubing inside the pinch valve. The instrument is performing within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2013-00291 |
| MDR Report Key | 3492912 |
| Report Source | 05,06 |
| Date Received | 2013-11-27 |
| Date of Report | 2013-11-01 |
| Date of Event | 2013-11-01 |
| Date Mfgr Received | 2013-11-01 |
| Date Added to Maude | 2014-03-10 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 |
| 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: |
| Product Code | CGN |
| Date Received | 2013-11-27 |
| Model Number | N/A |
| Catalog Number | 06891541 |
| Lot Number | 218 |
| ID Number | N/A |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2013-11-27 |