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 2017-08-31 for DIMENSION VISTA 500 manufactured by Siemens Healthcare Diagnostics Inc..
[84328126]
A siemens healthcare diagnostics inc. (siemens) customer service engineer (cse) was dispatched to the customer site to inspect the system. The cse reviewed system data and found abnormal assay flags for sample mixing. The cse replaced the sample mixer. The cause of the discordant low co2 result was the sample mixer. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[84328127]
A falsely low discordant carbon dioxide (co2) patient sample test result was obtained on a dimension vista 500. The initial result was not reported to the physician. The same sample was repeated on an alternate dimension vista 500. The repeat result was reported 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 | 2517506-2017-00669 |
| MDR Report Key | 6836090 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-31 |
| Date of Report | 2017-08-31 |
| Date of Event | 2017-08-15 |
| Date Mfgr Received | 2017-08-15 |
| Device Manufacturer Date | 2015-02-27 |
| Date Added to Maude | 2017-08-31 |
| 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 500 |
| Generic Name | DIMENSION VISTA 500 |
| Product Code | CHS |
| Date Received | 2017-08-31 |
| 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 500 |
| Generic Name | DIMENSION VISTA 500 |
| Product Code | JJE |
| Date Received | 2017-08-31 |
| 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 | 2017-08-31 |