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 2017-01-04 for ADVIA CENTAUR TESTOSTERONE II (TSTII) N/A 10696862 manufactured by Siemens Healthcare Diagnostics, Inc..
[63915729]
The validation/method comparison was performed in parallel with fresh samples for both the testosterone ii (tstii) and testosterone (tsto) assays. The data was generated for validation purposes only. The customer is now using the testosterone ii (tstii) assay to generate patient results and is no longer using the testosterone (tsto) assay. The cause for the discordant testosterone results is unknown. Siemens healthcare diagnostics is investigating.
Patient Sequence No: 1, Text Type: N, H10
[63915730]
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
[67547803]
Siemens filed the initial mdr 1219913-2016-00264 on january 04, 2017. On 01/05/2016 correction: the date of event was (b)(6) 2016. The date received by the manufacturer was 12/15/2016. On 01/06/2016 additional information: the advia centaur testosterone ii (tstii) assay has been aligned to the cdc hormone standardization (host) program. Tstii also demonstrates improved lower end sensitivity and precision. Customers will observe a difference in results based on these changes. The customer should expect low patient values to run lower on tstii and high patient values to run higher on tstii. Internal correlation data (n=128 in range of 8. 60-1394 ng/dl) demonstrates an overall bias of <10%. The data generated by siemens is similar to what's been represented in the customer data. The tstii assay is also standardized to the cdc lc-ms/ms method. Customer bulletin 11222821, rev. B, introducing the advia centaur testosterone ii and standardized shbg assays on the advia centaur, xp and xpt systems was issued september 2016. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2016-00264 |
| MDR Report Key | 6223279 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-04 |
| Date of Report | 2017-01-27 |
| Date of Event | 2016-12-14 |
| Date Mfgr Received | 2017-01-05 |
| Device Manufacturer Date | 2016-02-24 |
| Date Added to Maude | 2017-01-04 |
| 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 TESTOSTERONE II (TSTII) |
| Generic Name | TESTOSTERONE IMMUNOASSAY |
| Product Code | CDZ |
| Date Received | 2017-01-04 |
| Model Number | N/A |
| Catalog Number | 10696862 |
| Lot Number | 001 |
| Device Expiration Date | 2017-03-24 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2017-01-04 |