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 2017-02-08 for ADVIA CENTAUR TESTOSTERONE II (TSTII) N/A 10696862 manufactured by Siemens Healthcare Diagnostics, Inc..
[66862104]
The cause for the observed discordant advia centaur testosterone ii (tstii) results obtained during validation/method comparison when compared to the advia centaur testosterone (tsto) results is unknown. Siemens is investigating. The instruction for use under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings. "
Patient Sequence No: 1, Text Type: N, H10
[66862105]
Discordant advia centaur testosterone ii (tstii) results were obtained during validation/method comparison when compared to the advia centaur testosterone (tsto) results. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant testosterone ii (tstii) results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2017-00021 |
| MDR Report Key | 6312414 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-08 |
| Date of Report | 2017-02-08 |
| Date of Event | 2017-01-11 |
| Date Mfgr Received | 2017-01-13 |
| Device Manufacturer Date | 2016-02-24 |
| Date Added to Maude | 2017-02-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHEN PERRY |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604163 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST 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 TESTOSTERONE II (TSTII) |
| Generic Name | TESTOSTERONE IMMUNOASSAY, |
| Product Code | CDZ |
| Date Received | 2017-02-08 |
| Model Number | N/A |
| Catalog Number | 10696862 |
| Lot Number | 26611001 |
| Device Expiration Date | 2017-03-24 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-02-08 |