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 2015-12-22 for ADVIA CENTAUR XP TESTOSTERONE N/A 10309989 manufactured by Siemens Healthcare Diagnostics, Inc..
[34148812]
The customer performed troubleshooting by checking the water reservoir and then performed a dispense test on the reagent probe. The flow was checked for bleach. No bleach was detected in the system. The following recommendations were made to the customer: best practice when performing lot to lot comparison study is to use fresh materials and new calibrations for both lots, ideally using the same calibrator lot. The samples should be run on both lots as close as possible to the same time. Sample selection can make an impact on method comparison. Ideally the samples used should have concentrations which cover the entire measurement range of the assay. The cause for the discordant advia centaur xp testosterone results is unknown. The customer has requested service to be dispatched.
Patient Sequence No: 1, Text Type: N, H10
[34148813]
Discordant advia centaur xp testosterone results were obtained on samples from two patients during a lot to lot correlation study for reagent lot 177 and lot 178. The results were lower with lot 178. The quality control (qc) was out of range low for level 1. The same calibrator lot ce42 was used for both reagent lots. The customer loaded a new, well mixed testosterone reagent readypack and recalibrated. The qc was run and the results were acceptable. The patient samples were repeated and the results were similar. The results from lot 178 were not reported. 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
[35235186]
Siemens filed the initial mdr 1219913-2015-00200 on december 22, 2015. On 12/30/2015 additional information: service was not dispatched to the customer site. The loading of fresh materials caused the quality control (qc) to return to normal. The customer is satisfied and will continue testing with the advia centaur xp testosterone assay. The qc continues to be in range. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2015-00200 |
| MDR Report Key | 5318533 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-12-22 |
| Date of Report | 2015-12-01 |
| Date of Event | 2015-12-01 |
| Date Mfgr Received | 2015-12-30 |
| Device Manufacturer Date | 2015-03-31 |
| Date Added to Maude | 2015-12-22 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | 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 |
| Generic Name | RADLOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE |
| Product Code | CDZ |
| Date Received | 2015-12-22 |
| Model Number | N/A |
| Catalog Number | 10309989 |
| Lot Number | 178 |
| Device Expiration Date | 2016-05-31 |
| 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 | 2015-12-22 |