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 2018-12-17 for ADVIA CENTAUR XP AFP ASSAY N/A 10309979 manufactured by Siemens Healthcare Diagnostics, Inc..
[131792563]
The repeat testing was performed using the same sample, without additional centrifugation between initial and repeated measurements. The sample tube was a serum tube with gel separator from greiner bioone. The sample was centrifuged for 10 minutes at 2000xg after a clotting time of 30 minutes. The quality control and adjustment were valid. The performance of other tests was good, so system malfunction is unlikely. The cause for the discordant afp results is unknown. Siemens healthcare diagnostics is investigating. 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
[131792564]
A discordant high advia centaur xp afp result was obtained for a patient sample. The patient sample was repeated and the 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 | 1219913-2018-00302 |
| MDR Report Key | 8171216 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-12-17 |
| Date of Report | 2019-01-16 |
| Date of Event | 2018-11-28 |
| Date Mfgr Received | 2019-01-07 |
| Date Added to Maude | 2018-12-17 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP AFP ASSAY |
| Generic Name | AFP IMMUNOASSAY |
| Product Code | LOJ |
| Date Received | 2018-12-17 |
| Model Number | N/A |
| Catalog Number | 10309979 |
| Lot Number | 09370199 |
| Device Expiration Date | 2019-05-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-12-17 |