MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-08 for ADVIA CENTAUR? XPT BR (ASSAY FOR CA 27.29) N/A 10334837 manufactured by .
[142126461]
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 patient's medical history, clinical presentation and other findings. "
Patient Sequence No: 1, Text Type: N, H10
[142126462]
Advia centaur xpt br (assay for ca 27. 29) patient results were reported as ca 15-3 for the time period (b)(6) 2018 through (b)(6) 2019. The physicians were informed and there were no concerns reported. The customer previously ran ca15-3 on alternate method. The advia centaur xpt br assay was installed in october 2018 and correlated to the ca 15-3 on the alternate method. The customer did not realize that these were two different assays until the review of quality control (qc) peer data as the data did not match. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant br results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2019-00036 |
| MDR Report Key | 8404482 |
| Date Received | 2019-03-08 |
| Date of Report | 2019-04-02 |
| Date of Event | 2018-11-01 |
| Date Mfgr Received | 2019-03-11 |
| Device Manufacturer Date | 2018-07-19 |
| Date Added to Maude | 2019-03-08 |
| 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 | ADVIA CENTAUR? XPT BR (ASSAY FOR CA 27.29) |
| Generic Name | CA 27.29 ANTIGEN IMMUNOASSAY |
| Product Code | MOI |
| Date Received | 2019-03-08 |
| Model Number | N/A |
| Catalog Number | 10334837 |
| Lot Number | 047232 |
| Device Expiration Date | 2019-03-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-08 |