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 (TSTO) N/A 10322623 manufactured by Siemens Healthcare Diagnostics, Inc..
[63888253]
The cause for the difference in the correlation is unknown. Siemens reviewed the customers data and confirmed that the customer used frozen samples. The samples were first tested with the advia centaur testosterone assay and then tested on the advia centaur testosterone ii on the same day, on the same instrument. Siemens continues to investigate.
Patient Sequence No: 1, Text Type: N, H10
[63888254]
Customer performed a validation of the advia centaur testosterone ii and observed elevated results as compared to advia centaur testosterone results. There are no reports that treatment was altered or prescribed or adverse health consequences due to the low advia centaur testosterone results.
Patient Sequence No: 1, Text Type: D, B5
[65938751]
Mdr 1219913-2016-00265 was filed on january 4, 2017 reporting an elevated result on advia centaur testosterone ii compared to advia centaur testosterone. January 5, 2017 - additional information and correction: the initial mdr stated that the advia centaur testosterone ii (tstoii) result was elevated compared to advia centaur testosterone, while the data showed that the advia centaur testosterone ii result was depressed compared to advia centaur testosterone. The following information was not available at the time of the initial filing: advia centaur testosterone ii reagent lot 26611001 (part number 10696862) expiration date 2017/03/24 date of manufacture 2016/02/24 (b)(4). Siemens provided the following information to the customer: the advia centaur testosterone ii 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 (tsto vs. Tstii) based on these changes. They should expect low patient values to run lower on tstii and high patient values to run higher on tstii. This is similar to what's been represented your customers data. Assay results obtained at individual laboratories may vary from the data presented in (b)(4). Customers can minimize outside variables when performing correlations between by using material of the same age (preferably fresh) and run at the same time side by side. The selection of patient samples for the study is also very important and should represent equal proportions across the entire reportable range. Customers may also want to consider running the patient samples for method comparison n=2 on both assays and compare the means. Siemens continues to work with the customer to ensure that the performance of the advia centaur testosterone ii assay is acceptable.
Patient Sequence No: 1, Text Type: N, H10
[69463774]
Mdr 1219913-2016-00265 was filed on january 4, 2017 reporting an elevated result on advia centaur testosterone ii compared to advia centaur testosterone. Mdr 1219913-2016-00265 supplemental 1 was filed on january 19, 2017 with a correction and additional information regarding siemens' analysis of the complaint. February 28, 2017 - additional information: upon final review of the customer's data with the customer, siemens determined that the method comparison between the advia centaur testosterone assay and the advia centaur testosterone ii assay is expected. No further investigation is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2016-00265 |
| MDR Report Key | 6223467 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-04 |
| Date of Report | 2017-03-01 |
| Date of Event | 2016-11-22 |
| Date Mfgr Received | 2017-02-28 |
| Device Manufacturer Date | 2016-08-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LOUISE MCLAUGHLIN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604381 |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR TESTOSTERONE (TSTO) |
| Generic Name | TESTOSTERONE RADIOIMMUNOASSAY |
| Product Code | CDZ |
| Date Received | 2017-01-04 |
| Model Number | N/A |
| Catalog Number | 10322623 |
| Lot Number | 58071204 |
| Device Expiration Date | 2017-10-15 |
| 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 | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-04 |