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 2017-01-10 for ADVIA CENTAUR XPT AFP ASSAY N/A 03974780 manufactured by Siemens Healthcare Diagnostics, Inc..
[64343789]
No issues were identified for the advia centaur xpt unit 1 by the siemens field service engineer (fse). No problems were found in the event log at the time of the event. A secondary tube was used for the run on the advia centaur xpt unit 1. The sample was centrifuged at 3000 rpm for 5 minutes. The same secondary tube was used for the run on unit 3. The sample was not centrifuged prior to running on unit 3. A new secondary tube was used for the run on unit 12. The sample was not centrifuged prior to running on unit 12. The instructions for use (ifu) recommends centrifuging samples at 1000 x gravitational force (g) for 15-20 minutes to remove particulates. It is possible that some sort of particulate matter in the sample caused the initial elevated result. The cause for the discordant afp results is unknown. It is possible that insufficient centrifugation may have caused the initial elevated result. The instrument is performing within specification. No further evaluation of the device is required. The ifu states in the preparing the samples section: "before placing samples on the system, ensure that samples have the following characteristics: samples are free of fibrin or other particulate matter. Remove particulates by centrifugation at 1000 x g for 15-20 minutes. Samples are free of bubbles. " the ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. "
Patient Sequence No: 1, Text Type: N, H10
[64343790]
A falsely elevated advia centaur xpt afp result was obtained for a patient sample. The patient sample was repeated on two other advia centaur xpt instruments. Both results were lower. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant afp results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2016-00283 |
| MDR Report Key | 6237012 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-10 |
| Date of Report | 2017-01-10 |
| Date of Event | 2016-12-16 |
| Date Mfgr Received | 2016-12-16 |
| Device Manufacturer Date | 2016-06-28 |
| Date Added to Maude | 2017-01-10 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 XPT AFP ASSAY |
| Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
| Product Code | LOK |
| Date Received | 2017-01-10 |
| Model Number | N/A |
| Catalog Number | 03974780 |
| Lot Number | 041181 |
| Device Expiration Date | 2017-09-28 |
| 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 | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-10 |