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 2019-05-29 for ATELLICA IM 1300 ALPHA FETOPROTEIN (AFP) N/A 10995441 manufactured by Siemens Healthcare Diagnostics, Inc..
[146367802]
The cause for the elevated, non-reproducible afp result on the atellica im 1300 is unknown. Siemens has requested additional information to investigate the issue. The interpretation of results section of the instructions for use states: "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
[146367803]
Customer observed an elevated alpha fetoprotein (afp) result on the atellica im 1300 that did not match the clinical picture or repeat results. The result was reported to the physician who questioned the result. There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated atellica im afp result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2019-00098 |
| MDR Report Key | 8649352 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-29 |
| Date of Report | 2019-08-01 |
| Date of Event | 2019-05-06 |
| Date Mfgr Received | 2019-07-19 |
| Device Manufacturer Date | 2018-10-08 |
| Date Added to Maude | 2019-05-29 |
| 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 | LOUISE MCLAUGHLIN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604381 |
| 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 | ATELLICA IM 1300 ALPHA FETOPROTEIN (AFP) |
| Generic Name | AFP IMMUNOASSAY |
| Product Code | LOK |
| Date Received | 2019-05-29 |
| Model Number | N/A |
| Catalog Number | 10995441 |
| Lot Number | 10938208 |
| 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 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-29 |