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 2015-11-18 for ADVIA CENTAUR CP CA15-3 ASSAY N/A 10327620 manufactured by Siemens Heathcare Diagnostics, Inc..
[31571342]
Siemens performed an internal investigation. Siemens determined that some advia centaur systems (b)(4) 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 (b)(4) problem. No further action required.
Patient Sequence No: 1, Text Type: N, H10
[31571343]
The customer observed calibration failures due to high slope results exceeding defined ranges on two freshly opened reagent readypacks of advia centaur cp (b)(4) lot 043156. Acceptable calibration was obtained with when customer used another reagent readypack of the same lot. The two readypacks with failing calibrations were not used for sample measurement. There was no report of adverse health consequences due to the failed calibrations.
Patient Sequence No: 1, Text Type: D, B5
[34455529]
Siemens filed initial mdr 121993-2015-00179 on november 18, 2015. On 11/19/2015 - correction: section of the initial mdr had the incorrect date. The correct date is (b)(6) 2015.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2015-00179 |
| MDR Report Key | 5234159 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-11-18 |
| Date of Report | 2015-11-17 |
| Date of Event | 2015-04-16 |
| Date Mfgr Received | 2015-11-19 |
| 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 CP 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 | N |
| Device Age | DA |
| 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 |