MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-08-17 for DIMENSION VISTA 1500 10444802 manufactured by Siemens Healthcare Diagnostics Inc..
[83045941]
A siemens healthcare diagnostics inc. (siemens) regional support center (rsc) specialist analyzed the service method tests provided by the customer. The rsc did not detect any issue with the dimension vista 1500 instrument and the internal quality controls recovered within range at the time of the event. The cause of the discordant, falsely low co2 result is unknown. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[83045942]
A flagged, discordant, falsely low carbon dioxide (co2) result was obtained on a patient sample on the dimension vista 1500 instrument. The discordant result was not reported to the physician. The same patient sample was rerun in duplicate on the same instrument, resulting higher. The rerun result was provided to the physician. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low co2 result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00660 |
| MDR Report Key | 6802414 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-17 |
| Date of Report | 2017-09-11 |
| Date of Event | 2017-07-31 |
| Date Mfgr Received | 2017-08-30 |
| Device Manufacturer Date | 2016-11-15 |
| Date Added to Maude | 2017-08-17 |
| 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 | CHRISTINA LAM |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243504 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | 101 SILVERMINE ROAD REGISTRATION # : 1226181 |
| Manufacturer City | BROOKFIELD CT 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 | 2017-08-17 |
| Model Number | DIMENSION VISTA 1500 |
| Catalog Number | 10444802 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-08-17 |
| Model Number | DIMENSION VISTA 1500 |
| Catalog Number | 10444802 |
| Operator | HEALTH 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. |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-17 |