MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-04 for STRATUS CS STAT FLUOROMETRIC ANALYZER 10453531 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[52409674]
Customer was requested to return the samples if available for investigation. Customer indicated that they did not have samples as it had past stability time. Siemens requested to provide instrument log files to evaluate the event. The root cause for the event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[52409675]
Customer reported discordant troponin results on the analyzer. There was no report of injury due to this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-2016-00082 |
| MDR Report Key | 5846816 |
| Date Received | 2016-08-04 |
| Date of Report | 2016-08-04 |
| Date of Event | 2016-06-29 |
| Date Mfgr Received | 2016-07-08 |
| Date Added to Maude | 2016-08-04 |
| 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 | 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 |
| Manufacturer Street | 62 FLANDRES-BARTLEY RD. |
| Manufacturer City | FLANDERS NJ 07836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07836 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STRATUS CS STAT FLUOROMETRIC ANALYZER |
| Generic Name | STRATUS CS |
| Product Code | JHX |
| Date Received | 2016-08-04 |
| Catalog Number | 10453531 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| 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 | 2016-08-04 |