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 2016-02-18 for STRATUS CS manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[38527364]
Siemens is in process of investigating the issue. The cause for the discordant troponin results is unknown.
Patient Sequence No: 1, Text Type: N, H10
[38527365]
Customer reported falsely elevated troponin result on the analyzer. Customer wanted to know how viscosity affects troponin i result on the stratus cs. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[39870285]
Customer stated that the sample was clotted. Customer will not be returning reagent for investigation and provided log files did not include information for the date of the event. The presence of clots in a sample might have adversely affected the results. Siemens representative provided technical bulletin "the effects of sample integrity on accuracy and precision" to customer to educate them regarding the sample handling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2016-00017 |
| MDR Report Key | 5445932 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-02-18 |
| Date of Report | 2016-03-04 |
| Date of Event | 2016-01-29 |
| Date Mfgr Received | 2016-03-04 |
| Date Added to Maude | 2016-02-18 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | 2016-02-18 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| 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 | 2016-02-18 |