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 2018-11-16 for ADVIA CENTAUR XP CEA ASSAY N/A 10309977 manufactured by Siemens Healthcare Diagnostics, Inc..
[129314761]
The siemens application specialist transported the sample that was frozen at -20? C to another laboratory. Additional testing performed on the second patient sample on the advia centaur xpt and the immulite 2000 platforms. (b)(6) 2018 results: advia centaur xpt: 0,47 ng/ml (mean 2 dosages); immulite 2000 xpi: > 550 ng/ml (2 dosages); the sample was diluted in immulite 2000 xpi: automatic dilution 1/10: 2307 ng/ml; automatic dilution 1/20: 2518 ng/ml. 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. " mdr 1219913-2018-00274 and mdr 1219913-2018-00276 were filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[129314762]
A false low (normal) advia centaur xpt cea result was obtained on a patient sample. The result was reported to the physician and questioned. A new sample (second sample) was obtained by the laboratory. The patient sample was tested and the result was normal. The laboratory performed manual and automatic dilutions and the results were normal. The second sample was sent to (2) support laboratories using the same alternate method for testing and the results were high. A corrected report was issued. Patient undergoing cancer treatment. Patient treatment was not altered or prescribed. There was no report of adverse health consequences due to the discordant advia centaur xp cea results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2018-00275 |
| MDR Report Key | 8081205 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-16 |
| Date of Report | 2018-12-07 |
| Date of Event | 2018-10-31 |
| Date Mfgr Received | 2018-11-21 |
| Date Added to Maude | 2018-11-16 |
| 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 |
| 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 CEA ASSAY |
| Generic Name | CEA IMMUNOASSAY |
| Product Code | DHX |
| Date Received | 2018-11-16 |
| Model Number | N/A |
| Catalog Number | 10309977 |
| Lot Number | 05943176 |
| 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 | 2018-11-16 |