MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-11-07 for DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[3848510]
A discordant, falsely elevated potassium result was obtained on one patient sample on a dimension vista 1500 instrument. The discordant result was reported to the physician(s). The patient was sent to an emergency room (er) where they were retested and resulted normal. The laboratory then reran the patient sample on the same instrument and it resulted lower. The corrected result was provided to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated potassium result.
Patient Sequence No: 1, Text Type: D, B5
[11373833]
The siemens headquarter support center (hsc) evaluated the instrument data and did not find an instrument malfunction. Quality controls were within range and there were no discordant results on other samples processed in the same timeframe. The customer received the sample pre-centrifuged from another site and did not re-centrifuge prior to testing the sample, so centrigation data was not available for analysis. The cause of the discordant, falsely elevated potassium result on one patient sample is unknown. 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 | 1226181-2013-00482 |
| MDR Report Key | 3456994 |
| Report Source | 05,06 |
| Date Received | 2013-11-07 |
| Date of Report | 2013-10-15 |
| Date of Event | 2013-10-14 |
| Date Mfgr Received | 2013-10-15 |
| Device Manufacturer Date | 2009-08-14 |
| Date Added to Maude | 2014-02-05 |
| 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 | MZV |
| Date Received | 2013-11-07 |
| 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 | 2013-11-07 |