MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-08-14 for ADVIA CENTAUR XP TESTOSTERONE (TSTO) N/A 05476206 manufactured by Siemens Healthcare Diagnostics, Inc..
[4693037]
Elevated advia centaur xp testosterone results were obtained on samples from two different patients. Redraw samples were tested for both patients two weeks later and the results were in the normal reference range. The discordant results were questioned. No other repeat testing was performed. No testosterone enhancement pharmaceuticals were taken by patients. The patients were tested as part of a routine physical. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant advia centaur xp testosterone result.
Patient Sequence No: 1, Text Type: D, B5
[11950208]
The cause for the discordant advia centaur xp testosterone results is unknown. The cause for the elevated results maybe from pre-analytical factors during sample collection. The samples from the patients are not available for further testing and investigation. The instrument is performing within specification. No further evaluation of the device is required. The ifu states specimen collection and handling section: "before placing samples on the system, ensure that samples have the following characteristics: -samples are free of fibrin or other particulate matter. -samples are free of bubbles. "
Patient Sequence No: 1, Text Type: N, H10
[35267819]
Siemens filed the initial mdr 1219913-2014-00214 on august 14, 2014. On 10/14/2014 additional information:clarification was received regarding the initial result reported for patient 1. The initial result reported for patient 1 was 13,000 ng/dl. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2014-00214 |
| MDR Report Key | 4008720 |
| Report Source | 05,06 |
| Date Received | 2014-08-14 |
| Date of Report | 2014-07-15 |
| Date of Event | 2014-04-05 |
| Date Mfgr Received | 2014-10-14 |
| Date Added to Maude | 2014-08-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. EIMAN SULIEMAN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP TESTOSTERONE (TSTO) |
| Generic Name | TESTOSTERONE IMMUNOASSAY |
| Product Code | CDZ |
| Date Received | 2014-08-14 |
| Model Number | N/A |
| Catalog Number | 05476206 |
| Lot Number | 167 |
| ID Number | N/A |
| Device Expiration Date | 2014-11-17 |
| 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 | 2014-08-14 |