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 2019-01-29 for ATELLICA IM ALPHA FETOPROTEIN (AFP) N/A 10995441 manufactured by Siemens Healthcare Diagnostics, Inc..
[136747990]
A field service engineer (fse) was sent to the customer site for system inspection. No issues were identified. The quality control results were within specifications. The cause for the discordant afp results is unknown. Possible sample handling. 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 the patient's medical history, clinical presentation, and other findings. "
Patient Sequence No: 1, Text Type: N, H10
[136747991]
A false high atellica im alpha fetoprotein (afp) result was obtained for a patient sample. The patient sample was repeated on the advia centaur and the result was lower. The patient sample was repeated on the atellica im and the results were lower. A corrected report was issued. 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 | 1219913-2019-00009 |
| MDR Report Key | 8286065 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-01-29 |
| Date of Report | 2019-03-12 |
| Date of Event | 2019-01-08 |
| Date Mfgr Received | 2019-02-21 |
| Date Added to Maude | 2019-01-29 |
| 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 | ATELLICA IM ALPHA FETOPROTEIN (AFP) |
| Generic Name | AFP IMMUNOASSAY |
| Product Code | LOJ |
| Date Received | 2019-01-29 |
| Model Number | N/A |
| Catalog Number | 10995441 |
| Lot Number | 204 |
| 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 | 2019-01-29 |