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 2017-08-03 for ADVIA CENTAUR XPT CARCINOEMBRYONIC ANTIGEN ASSAY N/A 10309977 manufactured by Siemens Healthcare Diagnostics, Inc..
[81846126]
The cause for the false low advia centaur xpt results is unknown. Siemens is investigating. The instruction for use (ifu) 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) limitation 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. Warning: do not use the advia centaur cea immunoassay as a screening test for diagnosis. "
Patient Sequence No: 1, Text Type: N, H10
[81846127]
False low advia centaur xpt carcinoembryonic antigen (cea) results were obtained on a patient and considered discordant compared to higher cea results when tested on an alternate test method at another hospital. The physician questioned the lower advia centaur xpt cea results as they do not reflect the patient's clinical history. The laboratory reported both the advia centaur xpt cea result, and the alternate cea test method result to the physician. There is no known report that patient treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xpt cea results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2017-00167 |
| MDR Report Key | 6765408 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-03 |
| Date of Report | 2017-08-28 |
| Date of Event | 2016-11-07 |
| Date Mfgr Received | 2017-08-11 |
| Device Manufacturer Date | 2016-12-09 |
| Date Added to Maude | 2017-08-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHEN PERRY |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604163 |
| 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 | ADVIA CENTAUR XPT CARCINOEMBRYONIC ANTIGEN ASSAY |
| Generic Name | CEA IMMUNOASSAY, |
| Product Code | DHX |
| Date Received | 2017-08-03 |
| Model Number | N/A |
| Catalog Number | 10309977 |
| Lot Number | 040168 |
| Device Expiration Date | 2017-12-09 |
| 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 | 2017-08-03 |