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 2016-06-15 for STRATUS CS STAT FLUOROMETRIC ANALYZER 10444834 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[47417595]
Siemens is in process of issuing an urgent field safety notice to notify all affected customers and updating existing software to resolve the issue.
Patient Sequence No: 1, Text Type: N, H10
[47417596]
Siemens internally found that a testpak can be tested on the instrument regardless of the status of calibration and/or quality control if it is within the 48 hour window of lot expiry. A message is displayed next to the testpak lot number on screen alerting the customer that the testpak will expire within 48 hours. This message overwrites any other flags or messages that should be displayed when running a sample during the last 48 hours of use life. Siemens has not received any external complaint for the issue. There was no report of injury due to this issue.
Patient Sequence No: 1, Text Type: D, B5
[48007397]
Siemens healthcare is currently developing software updates to address this issue. Additional data:siemens issued an urgent field safety notice (poc 16-019. A. Us) to notify all the affected customers in june 2016.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2016-00065 |
| MDR Report Key | 5725827 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-06-15 |
| Date of Report | 2016-06-23 |
| Date of Event | 2016-05-17 |
| Date Mfgr Received | 2016-06-22 |
| Date Added to Maude | 2016-06-15 |
| 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 FLANDERS-BARTLEY RD. |
| Manufacturer City | FLANDERS NJ 07836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07836 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 1217157-06-17-2016-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRATUS CS STAT FLUOROMETRIC ANALYZER |
| Generic Name | STRATUS CS |
| Product Code | JHX |
| Date Received | 2016-06-15 |
| Catalog Number | 10444834 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2016-06-15 |