MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-09-22 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[87316554]
A siemens employee evaluated data provided by the customer. Analysis of the data did not identify a system issue. The cause of the discordant falsely low co2 result is unknown but a sample integrity issue is suspected. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[87316555]
A discordant falsely low carbon dioxide (co2) patient sample test result was obtained on a dimension vista 1500 system. The initial result was not reported to the physician. The same sample was repeated on the same system. The repeat result was reported to the physician. The repeat result is considered correct. There are no known reports of patient intervention or adverse health consequences due to the discordant results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00722 |
| MDR Report Key | 6885906 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-22 |
| Date of Report | 2017-09-22 |
| Date of Event | 2017-09-07 |
| Date Mfgr Received | 2017-09-07 |
| Device Manufacturer Date | 2016-04-26 |
| Date Added to Maude | 2017-09-22 |
| 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 | KARL AEBIG |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243102 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | REGISTRATION #: 1226181 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD DE 06804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA 1500 |
| Generic Name | DIMENSION VISTA 1500 |
| Product Code | CHS |
| Date Received | 2017-09-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Brand Name | DIMENSION VISTA 1500 |
| Generic Name | DIMENSION VISTA 1500 |
| Product Code | JJE |
| Date Received | 2017-09-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-22 |