MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-09-15 for STRATUS CS 10444834 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[19591552]
Customer reported discordant troponin results on the instrument. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[19978234]
Siemens field service engineer (fse) could not collect the event log because instrument was switched off. Fse performed repeatability test and quality control test and all the troponin results were in range.
Patient Sequence No: 1, Text Type: N, H10
[33503774]
The initial mdr was filed with the fda on september 16, 2014. Additional information: based upon the additional information, the issue was consistent with an outlier result due to sample handling (microclots, agglutination, fibrin formation) caused the false elevated result of 2. 48 ng/ml. Customer service engineer (cse) performed precision and qc testing to verify instrument operation. Cse indicated that message log was not available for review so the event could not be investigated further.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2014-00116 |
| MDR Report Key | 4090137 |
| Report Source | 06,07 |
| Date Received | 2014-09-15 |
| Date of Report | 2014-08-22 |
| Date of Event | 2014-08-21 |
| Date Mfgr Received | 2014-09-19 |
| Date Added to Maude | 2014-09-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVEN ANDBERG |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693655 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY |
| Manufacturer City | NEWARK DE 19702 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19702 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRATUS CS |
| Generic Name | STRATUS CS |
| Product Code | JHX |
| Date Received | 2014-09-15 |
| Catalog Number | 10444834 |
| Operator | OTHER HEALTH CARE 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 - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY NEWARK DE 19702 US 19702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-15 |