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 2015-12-15 for ADVIA CENTAUR XP CALIBRATOR E N/A 10309079 manufactured by Siemens Healthcare Diagnostics, Inc..
[33600332]
The cause for the discordant advia centaur xp testosterone results with calibrator lot ce43 is unknown. Siemens healthcare diagnostics is investigating. The instrument is performing within specifications.
Patient Sequence No: 1, Text Type: N, H10
[33600333]
Discordant advia centaur xp testosterone results were obtained on samples from eight patients during a lot to lot correlation study for reagent/calibrator (lot 036179 with ce42 and lot 036180 with ce43). A negative bias was observed for patient results. The quality control (qc) was out of range low for level 3 with calibrator ce43. The customer recalibrated with calibrator lot ce42 that was obtained from a sister laboratory. The qc was in range. Three of the patient samples were repeated with reagent lots 036179 and 036180 with calibrator lot ce42. The customer delayed reporting of results until after recalibration and qc was in range. The customer reported results with calibrator lot ce42. 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
[38880782]
Siemens filed the initial mdr 1219913-2015-00195 on december 15, 2015. 02/03/2016 additional information: siemens performed an internal investigation. Siemens confirmed a lot to lot bias with calibrator e for the advia centaur testosterone assay. The internal investigation demonstrates: an average positive bias of 17% across the assay range with calibrator e kit lots ending in 42 as compared to values generated with the master curve. An average negative bias of 7% across the assay range with calibrator e kit lots ending in 43 as compared to values generated with the master curve. The positive bias of calibrator e kit lots ending in 42 to the master curve compared to the negative bias of calibrator e kit lots ending in 43 to the master curve is the main driver for the negative bias between values generated with calibrator e kit lots ending in 42 and calibrator e kit lots ending in 43. Siemens issued urgent field safety notice cc 16-07. A. Ous and urgent medical device correction cc 16-07. A. Us on february 04, 2016 informing the customer of a lot to lot bias with calibrator e for the advia centaur testosterone assay. Instructions on actions to be taken by the customer are provided in the customer communication. The bias has been resolved with calibrator e kit lots ending in 44. Advia centaur/advia centaur xp/advia centaur xpt testosterone customers should use calibrator e kit lots ending in 44 and above. No further action required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2015-00195 |
| MDR Report Key | 5300706 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-12-15 |
| Date of Report | 2015-11-22 |
| Date of Event | 2015-11-22 |
| Date Mfgr Received | 2016-02-03 |
| Device Manufacturer Date | 2015-07-27 |
| Date Added to Maude | 2015-12-15 |
| 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 | 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 |
| Removal Correction Number | 1219913-02/04/2016-002-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP CALIBRATOR E |
| Generic Name | CALIBRATOR E |
| Product Code | JIS |
| Date Received | 2015-12-15 |
| Model Number | N/A |
| Catalog Number | 10309079 |
| Lot Number | CE43 |
| Device Expiration Date | 2016-11-27 |
| 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 | 2015-12-15 |