MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-03 for STRATUS CS 10444834 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[44898200]
Siemens evaluated the event; the message log file was received for instrument 98051871, the instrument in which the patient retesting was conducted, however upon review, the message log file only went back to the (b)(6) 2016. During log file investigation, a question was raised by the customer regarding edta contamination - the customer stated there might have been other bloods drawn at the time of the heparin draw (stratus cs) for the sample in question and they wondered how edta could affect the ctni result. The stratus cs ctni assay is not validated for use with edta because edta will disrupt the ctni complex, likely resulting in ctni recovery differences when compared with heparin plasma. Investigation conclusion: a review of the message log file from instrument 98050765 demonstrated normal and expected functioning of the instrument and sample. No system cause for the false positive ctni result could be found. A question was raised by the customer asking what the impact of edta contamination could be on the stratus cs ctni assay; edta is not validated for use with stratus cs ctni as it could cause recovery issues. It is unknown if there was actual contamination, but if edta contamination did occur the ctni results obtained from the contaminated sample would be questionable.
Patient Sequence No: 1, Text Type: N, H10
[44898201]
Customer reported discrepancy between troponin results on stratus cs analyzer. There was no report of injury due to the event.
Patient Sequence No: 1, Text Type: D, B5
[48536624]
Based on the review of the message log file from instrument (b)(4) demonstrated normal and expected functioning of the instrument and sample. No system cause for the false positive ctni result could be found. A question was raised by the customer asking what the impact of edta contamination could be on the stratus cs ctni assay; edta is not validated for use with stratus cs ctni as it could cause recovery issues. It is unknown if there was actual contamination, but if edta contamination did occur the ctni results obtained from the contaminated sample would be questionable. Siemens customer product support team spoke with operator during site visit and confirmed that the operator is well trained. Instrument is operational.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2016-00050 |
| MDR Report Key | 5625738 |
| Date Received | 2016-05-03 |
| Date of Report | 2016-06-30 |
| Date of Event | 2016-04-08 |
| Date Mfgr Received | 2016-06-27 |
| Date Added to Maude | 2016-05-03 |
| 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 | 2016-05-03 |
| Catalog Number | 10444834 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| 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 | 2016-05-03 |