MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-02 for STRATUS CS 10453571 manufactured by Siemens Healthcare Diagnostics Inc. - Glasgow.
[61603266]
Siemens issued an urgent field safety notice (# poc 16-019. A. Ous) in june 2016 informing customers of a software defect in the stratus cs acute care diagnostics system regarding testpak calibration and quality control (qc) status when a testpak is due to expire within 48 hours. As stated in the "actions to be taken by the customer" section of the urgent field safety notice: do not use testpaks that are due to expire within 48 hours. The customer acknowledged that they received the urgent field safety notice prior to this event. The customer reported that the testpak lot has been discarded.
Patient Sequence No: 1, Text Type: N, H10
[61603267]
The customer reported that they calibrated a ctni testpack that was about to expire and got an "*****above assay range" error message when a sample was run. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2016-00159 |
| MDR Report Key | 6141235 |
| Date Received | 2016-12-02 |
| Date of Report | 2016-12-02 |
| Date of Event | 2016-10-29 |
| Date Mfgr Received | 2016-11-09 |
| Date Added to Maude | 2016-12-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 |
| Removal Correction Number | Z-2525-2016 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STRATUS CS |
| Generic Name | STRATUS CS |
| Product Code | JHX |
| Date Received | 2016-12-02 |
| Catalog Number | 10453571 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-12-02 |