MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-01-31 for DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM DIMENSION VISTA 500 manufactured by Siemens Healthcare Diagnostics Inc..
[17282042]
A discordant, falsely elevated potassium result was obtained on one patient sample on a dimension vista 500 instrument. It is unknown if the discordant result was reported to the physician(s). The sample was repeated on an alternate dimension vista instrument and the same instrument, resulting lower on both. Additional results were provided for a sample that resulted high on the dimension vista 500 instrument and resulted lower upon repeat testing, but it is unknown if the sample was for the same patient or a different patient or which instrument(s) the sample was repeated on. It is unknown if any repeat results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated potassium result.
Patient Sequence No: 1, Text Type: D, B5
[17507057]
A siemens global product support specialist evaluated the instrument data and did not find a malfunction. It was also discovered that the other samples tested within the same time frame had resulted as expected. The cause of the discordant, falsely elevated potassium 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
| Report Number | 1226181-2014-00050 |
| MDR Report Key | 3601542 |
| Report Source | 05,06 |
| Date Received | 2014-01-31 |
| Date of Report | 2014-01-02 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-01-02 |
| Date Added to Maude | 2014-04-24 |
| 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 AVE |
| 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 ANALYZER |
| Product Code | MZV |
| Date Received | 2014-01-31 |
| Model Number | DIMENSION VISTA 500 |
| 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 RD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-31 |