MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-11-18 for ADVIA CENTAUR XP CA15-3 ASSAY N/A 10327620 manufactured by Siemens Heathcare Diagnostics, Inc..
[31529979]
Siemens performed an internal investigation. Siemens determined that some advia centaur systems ca15-3 reagent readypacks from lot 043156 fail to calibrate due to high slope caused by low relative light units (rlu) output while most reagent readypacks lot 043156 result in acceptable calibration. Customers are not able to perform quality control (qc) or report results due to the calibration failures when an affected readypack is used. Root cause was not determined prior to lot expiration, and the issue does not appear to be a systemic ca15-3 problem. No further action required.
Patient Sequence No: 1, Text Type: N, H10
[31529980]
Siemens personnel observed calibration failures due to slope results exceeding defined ranges on two different reagent readypacks of advia centaur xp ca15-3 lot 043156. Acceptable calibration results were observed with the use of different reagent readypacks of the same lot. Readypacks with failed calibrations had lower observed relative light units (rlus). There was no report of adverse health consequences due to the failed calibrations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2015-00178 |
| MDR Report Key | 5233239 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-11-18 |
| Date of Report | 2015-11-09 |
| Date of Event | 2015-01-12 |
| Date Mfgr Received | 2015-11-09 |
| Device Manufacturer Date | 2014-04-08 |
| Date Added to Maude | 2015-11-18 |
| 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 | STACY LOUKOS |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086685000 |
| 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 XP CA15-3 ASSAY |
| Generic Name | CHEMILUMINESCENCE IMMUNO ASSAY KIT FOR THE DETERMINATION OF CA 15-3 ANTIGEN |
| Product Code | MOI |
| Date Received | 2015-11-18 |
| Model Number | N/A |
| Catalog Number | 10327620 |
| Lot Number | 043156 |
| Device Expiration Date | 2015-04-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEATHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-18 |