MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-08-25 for STRATUS CS 10453571 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[4882248]
Customer reported discordant troponin results on the instrument. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[11996271]
Customer is being requested to provide a message log from instrument to investigate the event. The cause for the discordant troponin results is unknown at this moment.
Patient Sequence No: 1, Text Type: N, H10
[32604531]
The initial mdr 1217157-2014-00122 was filed with the fda on august 25, 2014. Additional information: the exl loci data was never collected so no information on that instrument could be reviewed. The exl troponin was consistent with the customer expectation for the patient. The message log for that time frame was not able to be collected as the instrument was shutdown prior to service reaching the site to collect the message log. The patient correlation results were concordant and did not show an issue with the stratus cs function. As per stratus cs troponin ifu: patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results. This assay has been designed to minimize interference from heterophilic antibodies. Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed. A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2014-00122 |
| MDR Report Key | 4034940 |
| Report Source | 06,07 |
| Date Received | 2014-08-25 |
| Date of Report | 2014-07-30 |
| Date of Event | 2014-06-21 |
| Date Mfgr Received | 2014-09-19 |
| Date Added to Maude | 2014-09-08 |
| 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 | 0 |
| Event Location | 0 |
| 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 | JHX |
| Date Received | 2014-08-25 |
| Catalog Number | 10453571 |
| 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 | 2014-08-25 |