MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-03-27 for DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[4265949]
Discordant, falsely elevated potassium results were obtained on multiple patient samples on a dimension vista 1500 instrument. Some discordant results were reported to the physician(s), though the customer did not specify which. The samples were repeated on an alternate dimension vista instrument and resulted lower. After troubleshooting, the samples were repeated on the same instrument and the alternate dimension vista instrument and all results matched the previous repeat results from the alternate dimension vista instrument. The corrected results were issued to the physician(s) for patients whose initial, discordant results had been reported. There are no known reports of adverse health consequences due to the discordant, falsely elevated potassium results.
Patient Sequence No: 1, Text Type: D, B5
[11606634]
The customer contacted the siemens technical solutions center (tsc). The customer stated that an instrument error message related to the water purification module (wpm) had prompted the operator to change the q-guard filter. The operator inadvertently replaced the q-guard filter with a pro-guard filter. Patient samples were run while the incorrect filter was installed. The operator had discovered the mistake and replaced the pro-guard filter with a new q-guard filter, but the instrument still showed an error message related to the wpm. Siemens service personnel emptied visited the customer site and refilled the wpm water tank twice, causing the resistivity to come into specification. The cause of the discordant results is unknown, as water from the wpm would not be used to dilute potassium samples. The cause of the incorrect filter being installed was a failure to follow instructions. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[11726723]
The initial mdr 1226181-2014-00168 was filed on (b)(4) 2014. Additional information ((b)(4) 2014): the initial result for one additional patient sample ((b)(6)) was discordant. The initial and repeat results have been added.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2014-00168 |
| MDR Report Key | 3706497 |
| Report Source | 05,06 |
| Date Received | 2014-03-27 |
| Date of Report | 2014-03-05 |
| Date of Event | 2014-03-05 |
| Date Mfgr Received | 2014-03-05 |
| Device Manufacturer Date | 2009-12-19 |
| Date Added to Maude | 2014-05-27 |
| 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 | 2014-03-27 |
| Model Number | DIMENSION VISTA 1500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2014-03-27 |