MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-11-17 for ADVIA CENTAUR XP CA 15-3 ASSAY N/A 10327620 manufactured by Siemens Healthcare Diagnostics, Inc..
[31393170]
A siemens field service engineer (fse) was sent to the customer site for system inspection. The fse found reagent probe 3 obstructed. The probe was slightly bent but would not have compromised (b)(6) results. The quality control was in range. The cause for the discordant advia centaur xp (b)(6) results is unknown. Possible fibrin or particulate matter in the sample. The instrument is performing within specifications. No further evaluation of the device is required. The ifu states in the preparing the samples section: "before placing samples on the system, ensure that samples have the following characteristics: -samples are free of fibrin or other particulate matter. Remove particulates by centrifugation at 1000 x g for 15-20 minutes. -samples are free of bubbles. " the ifu states in the limitation section: "note: do not interpret levels of ca 15-3 as absolute evidence of the presence or the absence of malignant disease. Before treatment, patients with confirmed breast carcinoma frequently have levels of ca 15-3 within the range observed in healthy individuals. Additionally, elevated levels of ca 15-3 can be observed in patients with nonmalignant diseases. Measurements of ca 15-3 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation. "
Patient Sequence No: 1, Text Type: N, H10
[31393171]
(b)(6) advia centaur xp (b)(6) results were obtained for a patient sample. The initial result obtained failed the customer's delta check. The patient sample was then repeated twice. The results were not reported. The patient sample was repeated on the second advia centaur xp. This result was similar to the third result from the first advia centaur xp and was reported out. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the (b)(6) results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2015-00170 |
| MDR Report Key | 5229300 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-11-17 |
| Date of Report | 2015-10-26 |
| Date of Event | 2015-10-26 |
| Date Mfgr Received | 2015-10-26 |
| Device Manufacturer Date | 2015-01-29 |
| Date Added to Maude | 2015-11-17 |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP CA 15-3 ASSAY |
| Generic Name | CA 15-3 IMMUNOASSAY |
| Product Code | MOI |
| Date Received | 2015-11-17 |
| Model Number | N/A |
| Catalog Number | 10327620 |
| Lot Number | 158 |
| Device Expiration Date | 2016-01-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-11-17 |