MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-11 for STRATUS CS 10444834 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[45160956]
Customer indicated that the original sample (plasma) is no longer available. This is the sample that was taken on (b)(6) which gave the 0. 73 ng/ml positive result. Customer wanted to know if a bubble in the sample could cause a false positive result? Siemens customer product support (cps) team cps stated that while a bubble in a sample could possibly cause an error to flag there is nothing to indicate that a bubble could lead to a false result. Siemens field service engineer performed post test, system check and auto alignments to check for gross adjustments. He also ran precision and controls. Biorad control lot 29830 trop test pak: level #1 0. 41, 0. 41, 0. 41, 0. 40. , sd=0. 005 cv=1. 350 level #3 5. 28, 5. 39, 5. , 08, 5. 22, sd=0. 130 cv=2. 48 all systems were passed with no issues and precision on controls were within parameters. The cause for the discordant troponin results is unknown.
Patient Sequence No: 1, Text Type: N, H10
[45160957]
Customer reported discordant troponin results on stratus cs analyzer. There was no report of injury due to the event.
Patient Sequence No: 1, Text Type: D, B5
[48201758]
This complaint is not confirmed. Numerous factors can contribute to a discrepant ctni result, including the instrument, reagent testpak, and operators. The cause of the discrepancy in results cannot be determined based up on the information that customer provided. The original sample was not available for investigation. System check was run and passed (b)(6). Qc is passing and customer ran a successful precision study. Technical bulletin "effects of sample integrity on accuracy and precision" has been reviewed with the customer. As per the ctni ifu samples should be inverted 8 to 10 times immediately after collection for complete anticoagulant mixing. Cellular debris is one possible cause of elevated test results. Instrument is operational. There is no evidence that a siemens product is not meeting specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2016-00055 |
| MDR Report Key | 5647825 |
| Date Received | 2016-05-11 |
| Date of Report | 2016-06-20 |
| Date of Event | 2016-04-14 |
| Date Mfgr Received | 2016-06-17 |
| Date Added to Maude | 2016-05-11 |
| 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 | 2016-05-11 |
| 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 | 2016-05-11 |