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 2019-05-30 for ADVIA CENTAUR XPT CEA N/A 10309977 manufactured by Siemens Healthcare Diagnostics, Inc..
[146517205]
The cause for the discordant advia centaur xpt cea result is unknown. Siemens healthcare diagnostics is investigating. The instruction for use (ifu) in the interpretation of results section states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. " the instruction for use (ifu) in the limitations section states: "warning do not use the advia centaur cea immunoassay as a screening test for diagnosis. Note: do not interpret levels of cea as absolute evidence of the presence or the absence of malignant disease. Measurements of cea should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation. The concentration of cea in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods, calibration, and reagent specificity. Cea determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity. "
Patient Sequence No: 1, Text Type: N, H10
[146517208]
Discordant advia centaur xpt cea results were obtained on samples from four patients during a comparison study. The comparison study was comparing the previous lot with the new lot that contained a new antibody pool. The results with the new lot were higher. Patient treatment was not altered or prescribed. There was no report of adverse health consequences due to the discordant advia centaur xpt cea results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2019-00099 |
| MDR Report Key | 8654231 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-30 |
| Date of Report | 2019-07-30 |
| Date of Event | 2019-05-08 |
| Date Mfgr Received | 2019-07-17 |
| Date Added to Maude | 2019-05-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 XPT CEA |
| Generic Name | CEA IMMUNOASSAY |
| Product Code | DHX |
| Date Received | 2019-05-30 |
| Model Number | N/A |
| Catalog Number | 10309977 |
| Lot Number | 41279185 |
| 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 | 2019-05-30 |