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 2018-04-17 for ADVIA CENTAUR XP CYCLOSPORINE (CSA) ASSAY N/A 10335448 manufactured by Siemens Healthcare Diagnostics, Inc..
[105901333]
The cause for the discordant advia centaur xp cyclosporine (csa) results is unknown. Siemens reviewed the customer data. The overall bias is in line with what is expected in the advia centaur cyclosporine ifu (instructions for use), 10629836_en rev, k, 2017-12 accuracy/method comparison section with tandem-ms. In addition the advia centaur cyclosporine assay does not have a claim to be comparable to any other methods or platforms. The lc/ms/ms methods also do not seem to be in alignment with each other and demonstrate variability. The instrument is performing within specifications. No further evaluation of the device is required. The ifu states in the interpretation of results: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. " the ifu states in the limitations section: "always use measurements of csa in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation. "
Patient Sequence No: 1, Text Type: N, H10
[105901334]
A high advia centaur xp cyclosporine (csa) result was obtained on a patient sample during a method comparison. The cyclosporine results were higher than the lc-ms/ms methods. The patient sample was tested on the lc-ms/ms at two laboratories. The initial results were reported and questioned by one physician. Corrected results were reported. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant cyclosporine (csa) results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2018-00130 |
| MDR Report Key | 7436765 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-17 |
| Date of Report | 2018-04-17 |
| Date of Event | 2018-01-15 |
| Date Mfgr Received | 2018-03-27 |
| Date Added to Maude | 2018-04-17 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 CYCLOSPORINE (CSA) ASSAY |
| Generic Name | CYCLOSPORINE ASSAY |
| Product Code | MKW |
| Date Received | 2018-04-17 |
| Model Number | N/A |
| Catalog Number | 10335448 |
| Lot Number | 77934031 |
| Device Expiration Date | 2019-05-01 |
| 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 | 2018-04-17 |