MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-10 for ADVIA CENTAUR XP CKMB ASSAY N/A 10309982 manufactured by Siemens Healthcare Diagnostics, Inc..
[67498677]
A siemens customer service engineer (cse) was sent to the customer's site for system inspection. There were no instrument issues found that may have contributed to the non reproduced elevated ckmb result. The customer had run master curve material (mcm) for troubleshooting, and the results for all levels were within acceptable ranges indicating that the assay is performing as expected. The cse made new calibrators, ckmb recalibration performed, and quality control (qc) results were acceptable. The cse ran the previously used calibrators made by the customer as test samples, and the results were observed to be higher. It is not known what the status of the qc was for that day as the customer did not provide qc data. The cause for the discordant, falsely elevated ckmb result may be attributed to compromised calibrator material. No conclusion can be drawn. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[67498678]
A falsely elevated advia centaur xp ckmb patient result was observed by the customer. The patient sample was retested on an alternate advia centaur system. All of the repeat ckmb results were lower. The initially discordant ckmb result was not reported to the physician. There is no known report of patient treatment being prescribed or altered. There is no report of adverse health consequences due to the discordant advia centaur xp ckmb patient result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2017-00022 |
| MDR Report Key | 6324255 |
| Date Received | 2017-02-10 |
| Date of Report | 2017-02-10 |
| Date of Event | 2017-01-11 |
| Date Mfgr Received | 2017-01-17 |
| Device Manufacturer Date | 2016-06-03 |
| Date Added to Maude | 2017-02-10 |
| 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 | MR. STEPHEN PERRY |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604163 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ADVIA CENTAUR XP CKMB ASSAY |
| Generic Name | CKMB IMMUNOASSAY |
| Product Code | JHS |
| Date Received | 2017-02-10 |
| Model Number | N/A |
| Catalog Number | 10309982 |
| Lot Number | 29986205 |
| Device Expiration Date | 2017-06-03 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| 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 | 2017-02-10 |