MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-05-20 for DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[3509544]
Discordant, low methotrexate results were obtained for one patient on a dimension vista 1500 instrument. The discordant results were reported to the physician(s), who questioned the results. The patient was redrawn and the new sample was tested on the same instrument and resulted higher. The initial and redraw samples were then tested on an alternate instrument, and the redraw sample results aligned with the redraw results from the dimension vista 1500. The initial sample resulted higher on the alternate instrument than from the dimension vista 1500. It is unknown if the rerun results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low methotrexate results.
Patient Sequence No: 1, Text Type: D, B5
[10725028]
Methotrexate is a user defined method (umd). For udms, the dimension vista system operator's guide states: "the customer assumes all responsibility for selecting the proper reagents and for entering the proper test parameters, using proper test protocols, determining the correctness of test results and resolving any associated errors or omissions. " the instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2013-00233 |
| MDR Report Key | 3120749 |
| Report Source | 01,05,06 |
| Date Received | 2013-05-20 |
| Date of Report | 2013-04-25 |
| Date of Event | 2013-04-24 |
| Date Mfgr Received | 2013-04-25 |
| Device Manufacturer Date | 2008-08-05 |
| Date Added to Maude | 2013-07-26 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 101 SILVERMINE ROAD |
| 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 CLINICAL CHEMISTRY SYSTEM |
| Generic Name | CLINICAL CHEMISTRY SYSTEM |
| Product Code | LAO |
| Date Received | 2013-05-20 |
| Model Number | DIMENSION VISTA 1500 |
| 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 | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-20 |