MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-11 for STRATUS CS 10444834 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[45160416]
Siemens has requested additional information from customer to further evaluate the event. The cause for the event is unknown at this moment.
Patient Sequence No: 1, Text Type: N, H10
[45160417]
Customer reported discrepancy between troponin results on stratus cs analyzer. There was no report of injury due to the event.
Patient Sequence No: 1, Text Type: D, B5
[47821819]
Message log was not available for investigation as instrument was turned off after the event. Qc is passing and complaint preparer has confirmed that customer is familiar with proper sample handling. Numerous factors can contribute to a discrepant ctni result, including the instrument, reagent testpak, and operators. The cause of the discrepancy in results cannot be determined based up on the information that customer provided. Customer has not had any further issues. Instrument is operational
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2016-00054 |
| MDR Report Key | 5646715 |
| Date Received | 2016-05-11 |
| Date of Report | 2016-06-15 |
| Date of Event | 2016-04-18 |
| Date Mfgr Received | 2016-06-10 |
| Date Added to Maude | 2016-05-11 |
| 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 - 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 | DAP |
| Date Received | 2016-05-11 |
| 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 | 2016-05-11 |