MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-07-09 for DIMENSION VISTA 500 manufactured by Siemens Healthcare Diagnostics Inc..
[18853972]
Discordant, falsely low sodium results were obtained for one patient sample on a dimension vista 500 instrument. The sample was run in duplicate and both resulted low. The discordant results were not reported to the physician(s). The sample was then rerun four times on another analyzer and all resulted higher than the initial results. The rerun results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low sodium results.
Patient Sequence No: 1, Text Type: D, B5
[19208372]
The customer contacted the siemens technical solutions center (tsc). After evaluation of the instrument data, the tsc specialist discovered the integrated multisensor technology (imt) and imt probe were misaligned and instructed the customer to align it. Once aligned, quality controls were run and within range. The cause of the discordant, falsely low sodium results is due to the misalignment of the imt and imt probe. This instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2013-00305 |
| MDR Report Key | 3212391 |
| Report Source | 05,06 |
| Date Received | 2013-07-09 |
| Date of Report | 2013-06-11 |
| Date of Event | 2013-06-11 |
| Date Mfgr Received | 2013-06-11 |
| Device Manufacturer Date | 2012-11-15 |
| Date Added to Maude | 2013-07-10 |
| 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 500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | NGS |
| Date Received | 2013-07-09 |
| Model Number | DIMENSION VISTA 500 |
| 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 | 2013-07-09 |