MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-29 for ADVIA CENTAUR XP PSA N/A 10310293 manufactured by Siemens Healthcare Diagnostics, Inc..
[93881962]
A siemens field service engineer (fse) was sent to the customer site. The fse performed a total service call and no issues were identified. The instrument was then calibrated with all new advia centaur psa lot 281 material and the mcms passed indicating lot 281 is performing as intended. The patient correlations after service and with all new advia centaur psa lot 281 material were acceptable to the customer. The cause of the high bias the customer originally had with the advia centaur psa lot 281 cannot be determined since new material was used after the instrument was serviced. Based on the available information, the advia centaur psa lot 281 is performing as intended. The cause for the discordant advia centaur xp psa results is unknown. The instrument is performing within specification. No further evaluation of the device is required. The ifu states in the limitations section: "note: do not interpret levels of psa as absolute evidence of the presence or the absence of malignant disease. Before treatment, patients with confirmed prostate carcinoma frequently have levels of psa within the range observed in healthy individuals. Elevated levels of psa can be observed in patients with nonmalignant diseases. Measurements of psa 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
[93881963]
Discordant high advia centaur xp psa results were obtained for samples from three patients when correlating reagent lot 277 and 281. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant psa result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2017-00227 |
| MDR Report Key | 7067599 |
| Date Received | 2017-11-29 |
| Date of Report | 2017-11-29 |
| Date of Event | 2017-11-06 |
| Date Mfgr Received | 2017-11-06 |
| Date Added to Maude | 2017-11-29 |
| 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 | WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ADVIA CENTAUR XP PSA |
| Generic Name | PROSTATE SPECIFIC ANTIGEN ASSAY (PSA) |
| Product Code | MTG |
| Date Received | 2017-11-29 |
| Model Number | N/A |
| Catalog Number | 10310293 |
| Lot Number | 89916281 |
| Device Expiration Date | 2018-05-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-11-29 |