MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-03-08 for STRATUS CS 10444834 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[39935507]
Siemens representative instructed customer to tape off the numbers on the test paks near the barcode with a white label and run it. Customer was able to scan and process the test with this work around. An urgent field safety notice has been provided to the customer. Siemens healthcare diagnostics issued an urgent field safety notice by e-mail to all affected siemens healthcare diagnostics regional offices on november 11, 2015 both in the united states and internationally for communication with affected customers. This notice informs customers of the issue and provides mitigation instructions.
Patient Sequence No: 1, Text Type: N, H10
[39935508]
Customer reported that they were not able to scan ckmb test pak on the instrument. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-2016-00026 |
| MDR Report Key | 5486674 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-03-08 |
| Date of Report | 2016-03-08 |
| Date of Event | 2016-02-14 |
| Date Mfgr Received | 2016-02-14 |
| Date Added to Maude | 2016-03-08 |
| 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 | 2016-03-08 |
| Catalog Number | 10444834 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-03-08 |